Estimated FDA User Fee Review Goals For Pending NDAs/BLAs

User fee goals are calculated based on the date of receipt. For applications submitted Oct. 1, 2012 and later, the timeframes are extended two months, to 12 months for standard review new molecular entitites and novel biologic entities and eight months for priority review NMEs and NBEs. Resubmissions with significant new data or analyses have a six-month goal. FDA may extend review timelines by three months.

SponsorProduct	Class/Indication	Submission/Receipt Date	Advisory Committee Status	Estimated User Fee Goal
Applications With User Fee Review Goals In February, March & April 2013
Alcon (Novartis) Brinzolamide/brimonidine^a	Fixed combination of the ophthalmic solution formulations of the carbonic anhydrase inhibitor (Azopt) and alpha-2 adrenergic agonist (Alphagan) for treatment of ocular hypertension in glaucoma patients	Q2 2012		2/2013-4/2013 (assuming standard review)
Allergan (MAP Pharmaceuticals) Levadex Dihydroergotamine	Ergot alkaloid formulated for oral inhalation using MAP’s TEMPO inhaler for acute treatment of migraine in adults	Announced 10/16/2012 (Resubmission following 3/26/2012 “complete response” letter; NDA submission announced 5/26/2011 under 505(b)(2) pathway)		4/15/2013
A.P. Pharma Granisetron (also known as APF530)	Long-acting subcutaneous injection formulation providing five days of therapy with the 5-HT3 antagonist utilizing the company’s proprietary Biochronomer delivery system for the prevention of acute and delayed-onset chemotherapy-induced nausea and vomiting	9/27/2012 (Resubmission following “complete response” letter announced 3/19/2010; NDA originally submitted 5/2009 under 505(b)(2) pathway)		3/27/2013
Ariad Pharmaceuticals Iclusig Ponatinib^b	Bcr-Abl tyrosine kinase inhibitor for treatment of patients with resistant or intolerant chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia	Announced 7/30/2012 (Rolling NDA for accelerated approval) MolecularMD announced withdrawal of companion T315I Bcr-Abl diagnostic PMA,submitted 7/30/2012, on 9/18/2012, after CDRH said it was not necessary		3/27/2013 (Priority review assigned) Approved 12/14/2012
Bayer HealthCare/Onyx Pharmaceuticals Stivarga Regorafenib^a	New indication for the multi-kinase inhibitor for oral treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) who have progressed despite prior therapy with two tyrosine kinase inhibitors (imatinib and sunitinib)	8/30/2012		3/2/2013 or earlier (Priority review assigned) Approved 2/25/2013
Biogen Idec Tecfidera Dimethyl fumarate^b (also known as BG-12)	Oral agent that activates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf-2) pathway for treatment of relapsing-remitting multiple sclerosis	Announced 2/28/2012		3/27/2013 (Standard review) (Goal date extended from 12/27/2012)
Boehringer Ingelheim Striverdi Olodaterol^b	Long-acting beta agonist formulated for use with BI’s Respimat inhaler as a single agent for once-daily treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema	5/2012	Advisory committee 1/29/2013 voted 15-1 (one abstention) that efficacy and safety were shown	3/2013
Bristol-Myers Squibb Co./Pfizer Inc. Eliquis Apixaban^b	Factor Xa inhibitor for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation	Announced 9/26/2012 (Full response to 6/22/2012 “complete response” letter; NDA originally submitted 9/28/2012)		3/17/2013 Approved 12/28/2012
Cangene BAT Botulism antitoxin heptavalent (A, B, C, D, E, F, G)-(Equine)^b	Polyclonal equine hyperimmune antibody preparation for treatment of symptomatic botulism following documented or suspected exposure to botulism neurotoxin serotypes A, B, C, D, E, F or G	9/20/2012 BLA seeks approval under Subpart H “animal rule”; accepted into U.S. Strategic National Stockpile in 2007	Advisory committee 2/12/2013 unanimously supported approval	3/22/2013 (Priority review assigned)
Celgene Pomalyst Pomalidomide^b	Oral immunomodulatory drug for treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy and who demonstrated disease progression on the last therapy	4/10/2012	Advisory committee review scheduled for 11/8/2012 cancelled	2/10/2013 (Standard review assigned) Approved 2/8/2013
Dynavax Heplisav ^b Vaccine, hepatitis B virus (rHBsAg-1018 ISS)	Vaccine that combines hepatitis B surface antigen with a novel Toll-like receptor 9 agonist adjuvant (1018 ISS) to enhance immune response, for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 to 70 years of age	Announced 4/26/2012	Advisory committee 11/15/2012 voted 13-1 that efficacy was shown but 8-5 (1 abstention) that safety data are inadequate	2/24/2013 (Priority review denied) “Complete response” letter announced 2/25/2013
Eisai Inc. Aciphex Rabeprazole^a	Expanded patient population for the proton pump inhibitor formulated as delayed-release sprinkle capsules in lower 5 mg and 10 mg doses for healing of gastroesophageal reflux disease, maintenance of healing of GERD and improvement of symptoms of GERD in children one to 11 years of age	9/2012		3/27/2013 (Priority review granted)
Genentech (Roche) Avastin Bevacizumab^a	Expanded indication for the anti-angiogenic monoclonal antibody to include second-line treatment of metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin-based chemotherapy, in patients who progressed on first-line regimens containing Avastin	8/6/2012		2/6/2013 or earlier (if priority review) Approved 1/23/2013
Genentech (Roche) Kadcyla Ado-trastuzumab emtansine^b (also known as T-DM1)	Antibody-drug conjugate using ImmunoGen’s TAP technology that links the monoclonal antibody trastuzumab (Herceptin) to the cytotoxic maytansinoid DM1 and delivers the drug directly into the cancer cell once the MAb has bound to the HER2 receptor, for treatment of unresectable locally advanced or metastatic HER2-positive breast cancer in patients previously treated with Herceptin and a taxane	Announced 8/27/2012 (Previous BLA submission requesting accelerated approval and priority review, announced 7/7/2010, received a “refuse to file” letter, announced 8/27/2010)		2/26/2013 (Priority review assigned) Approved 2/22/2013
Gilead Sciences Cobicistat^a	Mechanism-based inhibitor of cytochrome P450 3A that acts as a pharmacoenhancer to boost protease and integrase inhibitor activity (also a component of Gilead’s “Quad” fixed-dose combination Sirturo) for treatment of HIV infection	6/28/2012		4/28/2013 (Standard review assigned)
Gilead Sciences/Japan Tobacco Elvitegravir^a	Integrase inhibitor (also a component of Gilead’s “Quad” fixed-dose combination Sirturo) for treatment of HIV infection	6/27/2012		4/27/2013 (Standard review assigned)
GlaxoSmithKline Trametinib^b	MEK inhibitor for single-agent treatment of unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test	8/2/2012 bioMerieux submitted a PMA for a companion diagnostic to detect BRAF600E and K mutations		2/4/2013 (if priority review); 6/3/2013 (if standard)
Guerbet LLC Dotarem Gadoterate meglumine^b	Magnetic resonance imaging agent to detect and visualize areas with disruption of the blood/brain barrier and/or abnormal vascularity in the brain, spine and associated tissues of adult and pediatric patients (neonates and older)	9/20/2012	Advisory committee 2/14/2013 voted 17-0 that risk/benefit was acceptable in adults and children 2 years and older, but 10-6 (1 abstention) that it was not acceptable for children under 2 years old	3/20/2013 (Priority review assigned)
Hemispherx Biopharma Ampligen Rintatolimod^b (formerly known as PolyI:polyC12U)	Toll-like receptor 3 agonist for treatment of chronic fatigue syndrome	7/31/2012 (Class 2 response to 11/25/2009 “complete response” letter; NDA submitted 10/2008 but FDA refused to file, and sponsor submitted responses to FDA’s concerns in 1/2009 and 4/2009)	Advisory committee 12/20/2012 voted 8-5 that safety and efficacy data did not support approval	2/2/2013 “Complete response” letter announced 2/4/2013
Johnson & Johnson (Janssen)/Mitsubishi Tanabe Invokana Canagliflozin^b	Selective sodium glucose co-transporter 2 (SGLT2) inhibitor for oral treatment of adults with type 2 diabetes	5/31/2012	Advisory committee 1/10/2013 voted 10-5 in favor of approval	3/31/2013 (assuming standard review)
Johnson & Johnson/Bayer Xarelto Rivaroxaban^a	New indication for the oral Factor Xa inhibitor anticoagulant in combination with standard antiplatelet therapy to reduce the risk of stent thrombosis in Acute Coronary Syndrome patients	Announced 9/7/2012 (Original sNDA submission, announced 5/9/2012, was withdrawn after 6/21/2012 CRL for ACS secondary prevention sNDA)		3/7/2013 or earlier (if priority review); 7/7/2013 or earlier (if standard)
Johnson & Johnson/Bayer HealthCare Xarelto Rivaroxaban^a	New secondary prevention indication for the oral anticoagulant to reduce the risk of secondary thrombotic cardiovascular events in patients with Acute Coronary Syndrome	9/6/2012 (Full response to 6/21/2012 “complete response” letter)		3/6/2013 (Priority review assigned) “Complete response” letter announced 3/4/2013
Mallinckrodt/Nuvo Research Pennsaid 2% Diclofenac^a	New, more viscous formulation of the topical NSAID that is dosed twice daily via metered-dose pump bottle (vs. four-times daily as drops for marketed Pennsaid 1.5% formulation) for treatment of signs and symptoms of osteoarthritis of the knee	Q2 2012 (Mallinckrodt originally submitted as an sNDA, then resubmitted as an NDA in response to FDA request)		3/4/2013 “Complete response” letter announced 3/5/2013
Merck Atozet Ezetimibe/atorvastatin^a (Also known as MK-0653C)	Fixed-dose combination of the intestinal cholesterol absorption inhibitor and the statin for treatment of primary or mixed hyperlipidemia	Announced 1/2/2013 (resubmission after “complete response” letter announced 3/5/2012)		H1 2013
Merck Sugammadex^b (Previously known as Bridion)	Selective relaxant binding agent to reverse neuromuscular blockade induced by rocuronium and vecuronium as part of general anesthesia during surgical procedures	Q4 2012 (FDA acceptance of filing announced 1/7/2013; resubmission after “not approvable” letter announced 8/1/2008; originally submitted autumn 2007)		H1 2013 (Priority review assigned)
Navidea Pharmaceuticals (formerly Neoprobe) Lymphoseek Technetium Tc 99m tilmanocept^b	Radiolabelled receptor-targeted diagnostic tracing agent for use in connection with gamma detection devices in a surgical oncology procedure, Intraoperative Lymphatic Mapping, to help stage solid tumor cancers (breast cancer and melanoma) by identifying the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer	10/30/2012 (Class 2 response to 9/10/2012 “complete response” letter; original NDA submission announced 8/10/2011)		4/30/2013 Approved 3/13/2013
Novartis Afinitor Disperz Everolimus^a	New dosage form (tablets for oral suspension) and new patient population (children less than three years of age) for the mTOR inhibitor for treatment of pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that cannot be curatively resected	8/27/2012 (“Changes being effected” supplement requested by FDA)		2/27/2013 (assuming priority review) Accelerated approval granted 8/29/2012
Novartis Gleevec Imatinib^a	New indication for the Bcr-Abl tyrosine kinase inhibitor in combination with chemotherapy for treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia	4/27/2012		2/2013-4/2013 (if standard review); Q4 2012 (if priority review) Approved 1/25/2013
Novartis Zortress Everolimus^a	New indication for the mTOR inhibitor for prevention of organ transplant rejection following liver transplant in adults	10/24/2011		Early 2013 (Standard review) Approved 2/15/2013
Otsuka Pharmaceutical Co./H. Lundbeck A/S Abilify Maintena Aripiprazole^a,injectable depot suspension	New formulation of the dopamine D2 partial agonist as a once-monthly intramuscular depot injection for maintenance treatment of schizophrenia in adults	Announced 9/12/2012 (Class 2 response to 7/26/2012 “complete response” letter)		2/28/2013 Approved 2/28/2013
Pharmaxis Bronchitol Mannitol	Dry powder inhalation formulation of the osmotic six-carbon sugar alcohol for management of cystic fibrosis in patients ages six years and older to improve pulmonary function	5/2012	Advisory committee 1/30/2013 voted 14-0 against approval	3/18/2013
Raptor Pharmaceutical Procysbi Cysteamine, delayed-release (also known as RP103)	Delayed-release enteric coated microbead formulation of the cystine-depleting agent with twice-daily dosing, less frequent than immediate-release cysteamine (Mylan’s Cystagon), in capsules that can be broken to sprinkle on food for young patients, for treatment of the orphan lysosomal storage disease nephropathic cystinosis	Announced 3/30/2012		4/30/2013 (Priority review denied) (Goal date extended from 1/30/2013)
Roche Actemra Tocilizumab^a	New claim for the interleukin-6 receptor inhibitor for treatment of polyarticular-course juvenile idiopathic arthritis	6/2012		4/2013 (assuming standard review)
Roche Lucentis Ranibizumab^a	New dosing regimen of 0.5 mg administered as needed (prn; pro re nata) for the humanized anti-VEGF antibody fragment for the treatment of neovascular (wet) age-related macular degeneration	4/6/2012		2/6/2013 Approved 2/6/2013
Sanofi Pasteur Fluzone QIV IM Vaccine, influenza (quadrivalent)^a	Quadrivalent intramuscular inactivated formulation of the influenza vaccine that includes both A strains from trivalent Fluzone as well as two B strains, B/Victoria and B/Yamagata, for prophylaxis of influenza in adults and children six months of age and older	9/2012		Q2 2013
Shionogi Inc./QuatRx Pharmaceuticals Osphena Ospemifene^b	Selective estrogen receptor modulator for the oral treatment of vulvar and vaginal atrophy due to menopause	4/26/2012		2/26/2013 Approved 2/26/2013 for moderate to severe dyspaeunia, a symptom of vulvar/vaginal atrophy
Sucampo Pharmaceuticals/Takeda Pharmaceuticals USA Amitiza Lubiprostone^a	New indication for the oral chloride channel activator for treatment of opioid-induced constipation in patients with chronic, non-cancer pain	Announced 7/26/2012		Late 4/2013 (Priority review granted) (Goal date extended from late 1/2013)
Titan Pharmaceuticals/Braeburn Pharmaceuticals Probuphine Buprenorphine implant	Long-acting subdermal implant formulation of buprenorphine (available in sublingual tablets) using Titan’s ProNeura continuous drug delivery system for six months of maintenance treatment of opioid dependence in adults	Announced 10/29/2012 (Submitted under the 505(b)(2) pathway)	Advisory committtee review scheduled for 3/21/2013	4/30/2013 (Priority review granted)
Zogenix Zohydro ER Hydrocodone, extended-release	Oral single-entity (without acetaminophen) extended-release formulation of the opioid using Alkermes’ SODAS delivery technology for dosing every 12 hours for around-the-clock management of moderate to severe chronic pain	Announced 5/2/2012	Advisory committee 12/7/2012 voted against approval 11-2 (one abstention)	3/1/2013 (FDA said it is unlikely to issue a decision by the goal date)
Recently Announced NDA/BLA Submissions
Amarin Vascepa Icosapent ethyl^a	Expanded indication for the pure-EPA omega-3 prescription product (approved for severe hypertriglyceridemia, or TG ≥ 500 mg/dL) to treat adults with high triglycerides (TG ≥ 200 mg/dL and < 500 mg/dL) and mixed dyslipidemia	Announced 2/26/2013		12/26/2013 or earlier (assuming standard review)
Baxter International Feiba NF Anti-inhibitor coagulant complex^a	New use of the nanofiltered and vapor heated anti-inhibitor coagulant complex for prophylactic treatment of patients with hemophilia A or B with inhibitors to factor replacement therapy	Announced 2/26/2013		12/26/2013 or earlier
Ceptaris Therapeutics (formerly Yaupon Therapeutics) Mechlorethamine gel	Topical gel formulation of the chemotherapeutic agent for treatment of early stage (stages I-IIA) mycosis fungoides, a type of cutaneous T-cell lymphoma	Announced 2/27/2013 (NDA resubmission following 5/2012 “complete response” letter; NDA originally submitted 7/2011)		8/27/2013 or earlier
Delcath Systems Melblez Kit Melphalan chemosaturation system	Drug/device combination comprising high-dose Melblez (melphalan) chemotherapy with the Delcath Hepatic Delivery System for liver-targeted treatment of unresectable ocular melanoma that is metastatic to the liver (revised to exclude cutaneous melanoma, at FDA’s recommendation, from original inidication for unresectable metastatic melanoma in the liver)	8/15/2012 (FDA refused to file original 12/2010 NDA submission)	Advisory committee review scheduled for 5/2/2013	6/15/2013 (Priority review denied)
Hanmi Pharmeceutical/Amneal Pharmaceuticals Esomeprazole strontium, delayed-release	Salt of AstraZeneca’s proton pump inhibitor Nexium (esomeprazole magnesium) for use in acid-related gastrointestinal conditions including erosive esophagitis, gastroesophageal reflux disease, and reduction in risk of NSAID-associated gastrointestinal ulcers	10/15/2010 (additional development data subsquently provided) Submitted under 505(b)(2) pathway		4/29/2013
Novo Nordisk Catridecacog^b Factor XIII, recombinant (formerly known as NN-1841)	Recombinant coagulation Factor XIII as an alternative to FXIII derived from human plasma as once-monthly replacement therapy for prophylaxis of bleeding episodes in patients with congenital FXIII A-subunit deficiency	Q1 2013 (Resubmission following 12/2011 “complete response” letter; original BLA submission announced 2/23/2011)		Q3 2013
QRxPharma/Actavis (Watson) MoxDuo Morphine/oxycodone	Fixed-dose combination of the opioids in an immediate-release oral capsule for treatment of moderate to severe acute pain	Announced 2/28/2013 (Resubmission following 6/25/2012 “complete response” letter; NDA originally submitted 8/24/2011 under 505(b)(2) pathway)		8/28/2013 or earlier
Stallergenes SA Oralair Five-grass pollen extract allergy immunotherapy^b	Sublingual tablet allergy immunotherapy to prevent allergic reactions to the five most-common grass allergies, including perennial ryegrass, Kentucky bluegrass, timothy grass, orchard grass and sweet vernal grass	12/2012-1/2013 (BLA acceptance for review announced 2/18/2013)		12/2013-1/2014 (if standard review); 8/2013-9/2013 (if priority)
Sunovion (Dainippon Sumitomo)/BIAL Stedesa Eslicarbazepine^b	Voltage-gated sodium channel blocker and T-type calcium channel blocker for adjunctive treatment of partial-onset seizures in adults aged 18 years and older with epilepsy	FDA acceptance of NDA resubmission announced 2/27/2013 (Response to 4/2010 “complete response” letter; NDA originally submitted 3/2009)		Q3 2013
UCB Cimzia Certolizumab pegol^b	New indication for the PEGylated monoclonal antibody targeting tumor necrosis factor-alpha for treatment of adult patients with active psoriatic arthritis	Announced 2/20/2013		12/20/2013 or earlier (assuming standard review)
UCB Cimzia Certolizumab pegol^b	New indication for the PEGylated monoclonal antibody targeting tumor necrosis factor-alpha for treatment of adult patients with active axial spondyloarthritis (axSpA), including ankylosing spondylitis and axSpA without definitive radiographic evidence of AS (nr-axSpA)	Announced 2/20/2013		12/20/2013 or earlier (assuming standard review)
Applications With User Fee Goals In May 2013 And Beyond
AbbVie Levodopa/carbidopa intestinal gel^a (also known as LCIG and, outside U.S., Duodopa)	Gel formulation of levodopa and carbidopa administered directly to the small intestine via a procedurally implanted tube connected for a portable pump for up to 16 hours of continuous drug delivery for treatment of advanced Parkinson’s disease	Late 12/2012		10/2013 (if standard review); 6/2013 (if priority)
Actelion Opsumit Macitentan^b	Oral dual endothelin receptor antagonist for treatment of pulmonary arterial hypertension	10/19/2012		10/21/2013 (Standard review assigned)
AMAG Pharmaceuticals Feraheme Ferumoxytol^a	Broader indication for the iron oxide injection, expanding from the original indication, treatment of iron deficiency anemia in adults with chronic kidney disease, to treatment of all adult patients with IDA who have failed or could not tolerate oral iron treatment	Announced 12/24/2012		10/24/2013 or earlier (assuming standard review)
Antares Pharma Otrexup Methotrexate	Disease-modifying anti-rheumatic drug formulated for Antares’ Medi-Ject parenteral drug delivery system for subcutaneous administration with improved systemic availability compared with oral dosing for treatment of rheumatoid arthritis, poly-articular-course juvenile RA and moderate to severe psoriasis	Announced 12/17/2012		10/14/2013 (Standard review assigned)
Astellas Pharma Mycamine Micafungin^a	Expanded patient population for the I.V. echinocandin antifungal to include pediatric patients aged four months to 16 years old for treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses and esophageal candidiasis and prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation	9/2012		7/2013
Astellas Pharma Tacrolimus^a, extended-release	Once-daily oral capusule formulation of the calcineurin inhibitor immunosuppressant (Astellas’ Prograf, dosed every 12 hours) for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients	Announced 9/24/2012		7/21/2013
Astellas/Genentech Tarceva Erlotinib^a	New indication for the epidermal growth factor receptor tyrosine kinase inhibitor for first-line treatment of locally advanced or metastatic non-small cell lung cancer patients with tumors that have EGFR-activating mutations	Announced 11/20/2012 Companion diagnostic, Roche Molecular Diagnostics’ cobas EGFR Mutation Test, submitted to CDRH		5/20/2013 or earlier (Priority review assigned)
AstraZeneca Nexium Esomeprazole^a	New claim for the proton pump inhibitor for reduction in risk of low-dose aspirin-associated peptic ulcers and peptic ulcer bleeding	12/2012 (Response to 6/2011 “complete response” letter; first action letter announced 6/1/2010)		6/2013
Auxilium Xiaflex Collagenase clostridium histolyticum^a	New indication for the highly purified combination of two subtypes of collagenase for treatment of Peyronie’s disease	Announced 11/7/2012		9/6/2013 (Priority review denied)
AVEO Oncology/Astellas Pharma Tivopath Tivozanib^b	Oral tyrosine kinase inhibitor that targets vascular endothelial growth factor receptors 1, 2 and 3 for treatment of advanced renal cell carcinoma patients who have had no prior systemic therapy	9/28/2012	Advisory committee review scheduled for 5/2/2013	7/28/2013
Bayer/Algeta Radium-223 dichloride^b (formerly known as Alpharadin)	Alpha particle-emitting calcimimetic radiopharmaceutical for treatment of men with symptomatic castration-resistant prostate cancer with bone metastases	12/2012		8/2013 (Priority review assigned)
Bayer HealthCare Riociguat^b	Soluble guanylate cyclase stimulator for oral treatment of inoperable chronic thromboembolic pulmonary hypertension and treatment of pulmonary arterial hypertension	Announced 2/11/2013		8/11/2013 or earlier (if priority review); 2/11/2014 or earlier (if standard)
Baxter International BAX 326^b Factor IX, recombinant (rFIX)	Recombinant Factor IX protein for treatment and prophylaxis of bleeding episodes in patients with hemophilia B (also known as Christmas disease) who are over 12 years of age	Announced 9/4/2012		7/4/2013 or earlier (assuming standard review)
Biogen Idec/Swedish Orphan Biovitrum Factor IX Fc fusion protein, recombinant (rFIXFc)^b	Recombinant clotting factor developed using Biogen Idec’s monomeric Fc fusion technology to extend Factor IX’s circulating half-life, for long-lasting (every one to two weeks) treatment of hemophilia B	Q4 2012		Q4 2013 (Priority review request denied)
Boehringer Ingelheim Afatinib^b	Irreversible blocker of the ErbB family, which includes epidermal growth factor receptor, HER2 and ErbB4, for first-line treatment of locally advanced or metastatic non-small cell lung cancer with an EGFR mutation as detected by an FDA-approved test	Announced 1/16/2013 Qiagen is developing a companion diagnostic for EGFR mutations		Q3 2013 (Priority review assigned)
Cubist Pharmaceuticals Entereg Alvimopan^a	Expanded indication for the peripherally acting mu-opioid receptor antagonist, currently approved for patients undergoing surgery for colorectal disease, to accelerate gastrointestinal recovery following any surgery that includes a bowel resection with primary anastomosis	Announced 12/21/2012		10/21/2013 or earlier (if standard review)
Depomed Sefelsa Gabapentin extended-release (formerly known as Serada)	Extended-release formulation of the antipsychotic, using Depomed’s Acuform oral delivery technology to target ER delivery to the upper GI tract when dosed with food, for non-hormonal treatment of moderate to severe vasomotor symptoms due to menopause	7/31/2012	Advisory committee 3/4/2013 voted 12-2 against recommending approval	5/31/2013 (Standard review assigned) Depomed will cease spending on Sefelsa until it sees “a positive direction.”
Ferring Pharmaceuticals Misoprostol vaginal insert	Controlled-release removable formulation of the prostaglandin for decreasing time to vaginal delivery in women with an unfavorable cervix (a cervix that has not yet softened or thinned so that dilation can take place) when used in sequential regimen with oxytocin augmentation, if needed	Announced 10/23/2012		8/23/2013 or earlier (assuming standard review)
Forest Laboratories/Gedeon Richter Cariprazine^b	Dopamine D3-preferring D3/D2 receptor partial agonist for treatment of schizophrenia and acute treatment of manic or mixed episodes associated with Bipolar I Disorder	Announced 11/28/2012		11/28/2013 or earlier (assuming standard review)
Forest Laboratories/Pierre Fabre Levomilnacipran^b (also known as 1S, 2R-milnacipran)	Enantiomer of the racemic serotonin norepinephrine reuptake inhibitor milnacipran (Forest’s fibromyalgia therapy Savella) formulated for sustained release for once-daily treatment of major depressive disorder in adults	Announced 9/27/2012		7/27/2013 or earlier
GE Healthcare [^18F]flutemetamol^b	Amyloid imaging agent for positron emission tomography (PET) for use in the visual detection of beta amyloid in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease or other cognitive disorders	Q4 2012 (FDA acceptance of NDA announced 1/8/2013)		Q4 2013 (if standard review); Q3 2013 (if priority)
GlaxoSmithKline Albiglutide^b	Glucagon-like peptide 1 receptor agonist comprised of two copies of modified human GLP-1 fused in series to human albumin for once-weekly subcutaneous injection for treatment of type 2 diabetes	1/14/2013		1/14/2014 (if standard review); 9/14/2013 (if priority)
GlaxoSmithKline/Theravance Anoro Ellipta Umeclidinium^b/vilanterol^b	Fixed-dose combination of the inhaled long-acting muscarinic antagonist and long-acting beta agonist (vilanterol is also pending in combination with fluticasone as Breo) delivered by the Ellipta dry powder inhaler for long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema	12/18/2012		12/18/2013 (Standard review assigned)
GlaxoSmithKline/Theravance Breo Ellipta Fluticasone furoate/vilanterol^b (formerly known as Relovair)	Once-daily inhaled combination of the corticosteroid and the novel long-acting beta2 agonist, administered by the Ellipta dry powder inhaler, for long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, and to reduce exacerbations of COPD in patients with a history of exacerbations	7/12/2012	Advisory committee review scheduled for 3/7/2013 postponed	5/12/2013
GlaxoSmithKline Dabrafenib^b	BRAF inhibitor for single-agent treatment of unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test	7/30/2012 bioMerieux submitted a PMA for a companion diagnostic to detect BRAF600E and K mutations		5/30/2013 (if standard) review); 1/30/2013 (if priority)
GlaxoSmithKline Vaccine, influenza (quadrivalent)^a (also known as Q-QIV)	Quadrivalent seasonal influenza vaccine containing two influenza A strains (A/H1N1 and A/H3N2) and two influenza B strains (from the Victoria and Yamagata lineages), manufactured in Quebec, Canada, for active immunization of adults and children 3 years and older	10/2012		8/2013 (assuming standard review)
Johnson & Johnson (Janssen) Canagliflozin^b/metformin	Fixed-dose combination of the selective sodium glucose co-transporter 2 inhibitor (also pending as a single agent) and the immediate-release biguanide for treatment of type 2 diabetes	Announced 12/12/2012		Q4 2013
Johnson & Johnson (Janssen) Simponi Golimumab^a	New indication for the anti-tumor necrosis factor alpha monoclonal antibody for treatment of adults with moderately to severely active ulcerative colitis who had inadequate response to conventional therapy	7/2012		5/2013
Johnson & Johnson (Janssen) Simponi Golimumab^a	New intravenous formulation of the anti-tumor necrosis factor alpha monoclonal antibody (approved for subcutaneous injection) for treatment of adults with moderately to severely active rheumatoid arthritis	Announced 9/18/2012		7/18/2013 or earlier (Standard review assigned)
Johnson & Johnson (Janssen) Stelara Ustekinumab^a	New indication for the anti-interleukin-12/23 monoclonal antibody for treatment of adult patients with active psoriatic arthritis	11/2012		9/2013 (assuming standard review)
Medicure Aggrastat Tirofiban^a	New high dose bolus dosing regimen of the non-peptide reversible GP IIb/IIa receptor antagonist for treatment of acute coronary syndrome	Announced 1/8/2013		11/8/2013 or earlier
Merck/ALK-Abello MK-7243 Allergy immunotherapy sublingual tablet (AIT), grass pollen^b	Dissolvable oral immunotherapeutic biologic to prevent allergy symptoms by inducing protective immune response against allergies for treatment of grass (Phleum pratense) pollen-induced allergic rhinoconjunctivitis	1/2012		1/2014 (if standard review); 9/2013 (if priority)
Merck Suvorexant^b	Orexin receptor antagonist for treatment of insomnia patients with difficulty falling asleep (sleep onset) or staying asleep (sleep maintenance)	9/2012-11/2012 (FDA acceptance announced 11/8/2012)		7/2013-11/2013 (Standard review assigned; 12-month user fee goal applies if submitted 10/1/2012 or later)
Novartis Ilaris Canakinumab^a	New indication for the interleukin-1 beta blocker for treatment of systemic juvenile idiopathic arthritis	H2 2012		H2 2013
Novartis TOBI Podhaler Tobramycin inhalation powder^a (also known as TIP)	Dry powder inhalation formulation of the aminoglycoside antibiotic (available as a solution for inhalation as TOBI) for management of cystic fibrosis patients infected with Pseudomonas aeruginosa	10/2012 (Response to 10/2012 “complete response” letter; originally submitted Q4 2011)	Advisory committee 9/5/2012 voted 13-1 that safety and efficacy had been shown	Mid-2013
Noven Pharmaceuticals (Hisamitsu Pharmaceutical) Paroxetine mesylate (also known as LDMP)	Low-dose mesylate salt of paroxetine (LMDP), a selective serotonin reuptake inhibitor, for non-hormonal treatment of moderate to severe vasomotor symptoms of menopause	Announced 8/29/2012	Advisory committee 3/4/2013 voted 10-4 that the overall risk/benefit ratio is not acceptable	6/28/2013
Novo Nordisk Turoctocog alfa^b (also known as NN7008)	Third-generation recombinant coagulation factor VIII for prevention and treatment of bleeding in patients with hemophilia A	Announced 10/16/2012		10/16/2013 or earlier (assuming standard review)
Orexo AB Zubsolv Buprenorphine/naloxone	Fast-dissolving sublingual tablet formulation of the partial mu-opioid receptor agonist/kappa-opioid receptor antagonist and the mu-opioid receptor antagonist with increased bioavailability allowing a lower dose, accelerated dissolve time, reduced tablet size, and improved taste compared with Reckitt Benckiser’s Suboxone slow-dissolving sublingual buprenorphine/naloxone tablet, for treatment of opioid dependence	9/6/2012 Submitted under the 505(b)(2) pathway		7/6/2013 (Standard review assigned)
Pfizer Inc./Ligand Pharmaceuticals Bazedoxifene^b/conjugated estrogens	Combination of the selective estrogen receptor modulator and conjugated estrogens for the treatment of non-hysterectomized women with moderate-to-severe vasomotor symptoms and vulvar and vaginal atrophy associated with menopause and for the prevention of post-menopausal osteoporosis	10/2012 (acceptance for review announced 12/13/2012)		10/3/2013 (Standard review assigned)
Roche Actemra Tocilizumab^a	New subcutaneous formulation of the interleukin-6 receptor inhibitor for monotherapy treatment of adult rheumatoid arthritis patients who have had an inadequate response to disease-modifying antirheumatic drugs or to tumor necrosis factor inhibitors	12/2012		10/2013 (Standard review assigned)
Sanofi/Bayer Healthcare Lemtrada Alemtuzumab^a	Monoclonal antibody targeting the CD52 protein on T and B cells (previously approved as Campath in oncology, which is being withdrawn from market) for treatment of relapsing forms of multiple sclerosis	Late 2012 (FDA acceptance for review announced 1/28/2013; original 6/2012 sBLA received refuse-to-file letter 8/2012)		Second half 2013 (Standard review assigned)
Sanofi/Zealand Pharma Lixisenatide^b (Lyxumia in Europe)	Glucagon-like peptide-1 agonist for once-daily treatment of type 2 diabetes	Late 12/2012		Late 12/2013 or earlier (assuming standard review)
Sunovion Pharmaceuticals Latuda Lurasidone^a	New indication for the atypical antipsychotic for monotherapy of adult patients with depressive episodes associated with bipolar I disorder (bipolar depression)	Announced 9/6/2012		7/6/2013 or earlier
Sunovion Pharmaceuticals Latuda Lurasidone^a	New indication for the atypical antipsychotic as adjunctive therapy to lithium or valproate in adult patients with depressive episodes associated with bipolar I disorder (bipolar depression)	Announced 9/6/2012		7/6/2013 or earlier
Takeda/Lundbeck Brintellix Vortioxetine^b	Multimodal antidepressant that works by receptor activity modulations and reuptake inhibition as a 5-HT3 and 5-HT7 antagonist, 5-HT1B partial agonist, 5-HT1A agonist and serotonin transporter (SERT) inhibitor, for treatment of major depressive disorder in adults	Announced 10/2/2012		10/2/2013 (Standard review assigned)
Teva Pharmaceutical Balugrastim^b	Long-acting recombinant granulocyte colony stimulating factor formulated with albumin-fusion technology from Human Genome Sciences to prolong plasma half-life with a profile comparable to Amgen’s Neulasta (pegfilgrastim) to reduce the risk of infection in cancer patients receiving chemotherapy who are at risk of neutropenia	12/2012 (To resolve patent litigation with Amgen, Teva agreed not to market balugrastim in the U.S. prior to 11/10/2013)		12/2013 (if submitted as an NME, not a biosimilar, receiving standard review)
Teva Pharmaceutical Lonquex Lipegfilgrastim^b (also known as XM-22)	Long-acting recombinant granulocyte colony stimulating factor formulated with glycopegylation technology to prolong half-life as a “bio-better” agent comparable to Amgen’s Neulasta (pegfilgrastim) to reduce the risk of infection in cancer patients receiving chemotherapy who are at risk of neutropenia	12/2012		12/2013 (if submitted as an NME, not a biosimilar, receiving standard review)
Teva Pharmaceutical Quartette Levonorgestrel/ethinyl estradiol and ethinyl estradiol	Ascending-dose extended-regimen (91-day cycle) oral contraceptive for the prevention of pregnancy	10/2012 or earlier		8/2013 or earlier
Valeant Pharmaceuticals/Kaken Pharmaceutical Efinaconazole^b (formerly IDP-108)	Triazole antifungal formulated as a non-lacquer 10% topical solution for treatment of distal lateral subungual onychomycosis	7/2012		5/26/2013 (Standard review assigned)
ViiV Healthcare (GlaxoSmithKline/Pfizer/Shionogi) Dolutegravir^b	Integrase inhibitor for the treatment of HIV infection in adults and adolescents aged 12 years and older	12/17/2012		8/17/2013 (Priority review assigned)
Warner Chilcott Delzicol Mesalamine^a	New 400 mg delayed-release capsule formulation of the aminosalicylate that does not contain the plasticizer dibutyl phthalate (to replace the company’s Asacol mesalamine brand) for treatment of mild to moderately active ulcerative colitis and maintenance of remission of ulcerative colitis	8/1/2012		6/1/2013 (Standard review assigned) Approved 2/1/2013
Applications Past Original User Fee Goals
Amylin Pharmaceuticals (acquired by Bristol-Myers Squibb) Metreleptin^b	Analog of the human hormone leptin for treatment of diabetes and/or hypertriglyceridemia in pediatric and adult patients with rare forms of lipodystrophy	Announced 4/3/2012 (Completion of rolling BLA submission)		1/2013 (Extension of user fee goal from 10/2012 is likely, assuming FDA granted request for priority review)
BioAlliance Pharma Sitavig Acyclovir	New formulation of the antiviral using BioAlliance’s Lauriad mucoadhesive buccal tablet technology for treatment of recurrent orofacial herpes	Q1 2012		12/2012-1/2013
Cangene (acquired through Inspiration Biopharmaceuticals’ bankruptcy proceedings 2/2013) Factor IX, recombinant (also known as IB1001)	Intravenous recombinant Factor IX protein for treatment and prevention of bleeding episodes in patients with hemophilia B	3/2012 (Two ongoing Phase III studies were placed on clinical hold 7/2012 due to higher than expected incidence of anti-CHO antibodies; Inspiration implemented manufacturing process changes to reduce levels of host cell protein responsible for immunological responses)		1/2013 (assuming standard review) “Complete response” letter issued 2/2013
GlaxoSmithKline Q-Pan H5N1 Vaccine, influenza A H5N1/AS03 adjuvant^b	Pandemic influenza A H5N1 (“bird flu”) vaccine formulated with GSK’s novel AS03 adjuvant system containing tocopherol and squalene in an oil and water emulsion for immunization of adults age 18 and older who are at increased risk of exposure or during an epidemic	Announced 3/5/2012 (BLA seeks accelerated approval)	Advisory committee 11/14/2012 voted 14-0 that immunogenicity and safety data support approval	1/5/2013 or earlier (if standard review)
Merck (Schering-Plough) Implanon NXT Etonogestrel^a	New device and next-generation single-rod formulation of the implantable contraceptive for prevention of pregnancy	Application accepted by FDA 9/2009		Mid-2010
Novo Nordisk Ryzodeg Insulin degludec^b/insulin aspart	Soluble insulin combination of the ultra-long-acting basal insulin analog with a bolus boost of rapid-acting insulin (NovoRapid) in a fixed ratio of 70% degludec and 30% aspart for treatment of type 1 and type 2 diabetes	9/29/2011	Advisory committee 11/8/2012 voted 8-4 in favor of approval	10/29/2012 (Goal date extended from 7/29/2012 for major amendment) “Complete response” letter received 2/8/2013
Novo Nordisk Tresiba Insulin degludec^b	Ultra-long-acting basal insulin analog that forms multi-hexamers upon subcutaneous injection, resulting in a soluble depot, for treatment of type 1 and type 2 diabetes	9/29/2011	Advisory committee 11/8/2012 voted 8-4 in favor of approval	10/29/2012 (Goal date extended from 7/29/2012 for major amendment) “Complete response” letter received 2/8/2013
Octapharma AG Octagam 10% Immune globulin intravenous [human] 10%^a	New 10 percent formulation of the I.V. immune globulin, approved in a 5 percent formulation as Octagam, for treatment of idiopathic thrombocytopenic purpura	Announced 9/23/2009		7/23/2010 or earlier (Octagam 5% was withdrawn starting 8/2010 due to increases in thromboembolic events; FDA cleared return to market 11/3/2011)
Octapharma AG Octaplas Human plasma proteins, solvent/detergent treated (also known as octaplasLG)	Cell-free therapeutic coagulation-active plasma that undergoes solvent/detergent inactivation against enveloped viruses and immune neutralization against non-enveloped viruses using ProMetic BioSciences’ prion affinity ligand gel, for the management of preoperative or bleeding patients who require replacement of multiple coagulation factors and for substitution of intentionally removed plasma, such as plasma exchange in patients with thrombotic thrombocytopenic purpura	Announced 2/24/2012	Advisory committee 9/20/2012 voted that efficacy was shown in preop patients (8-4, with 3 abstentions) and plasma exchange (10-2, 3 abstentions) and that safety was shown (12-3)	10/22/2012 Approved 1/17/2013
Pfizer Pristiq Desvenlafaxine^a	New indication for the serotonin-norepinephrine reuptake inhibitor for treatment of moderate-to-severe vasomotor symptoms associated with menopause	12/2010 (Response to 7/2007 “complete response” letter; sNDA originally submitted 6/2006)		6/2011 (Second “complete response” letter announced 9/8/2011) Discontinued 2012
Protein Sciences FluBlok Influenza vaccine, recombinant hemagglutinin	Cell culture-produced trivalent recombinant hemagglutinin influenza vaccine based on a baculovirus expression system derived from the fall armyworm (Spodoptera frugiperda) for seasonal prevention of influenza caused by viral subtypes A and B in adults aged 18 years and older	4/28/2009 (Sponsor's full response to 8/29/2008 "complete response" letter. BLA originally submitted 4/18/2008)	Advisory committee 11/19/2009 voted 6-5 that safety evidence was insufficient; voted 9-2 that efficacy in 18-49 year olds was shown; voted 6-5 that efficacy in adults age 50-64 was not shown; and voted 9-2 that efficacy was not shown in adults 65 years and older	10/28/2009 (Sponsor says the vaccine is under “final review” by FDA as of 7/2012) Approved 1/16/2013
Salix Pharmaceuticals/ Napo Pharmaceuticals Fulyzaq Crofelemer^b	Anti-secretory agent derived from the South American tree Croton lecheri that inhibits chloride secretion by inhibiting gut cystic fibrosis transmembrane conductance regulator protein and gut calcium-activated chloride channels for treatment of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy	Announced 12/14/2011		9/5/2012 (Priority review) (User fee goal extended from 6/5/2012) Review continues past PDUFA goal to address production and control of the botanical active ingredient Approved 12/31/2012
Takeda Kazano Alogliptin/metformin	Fixed-dose combination of the dipeptidyl peptidase IV inhibitor and the biguanide for treatment of type 2 diabetes	11/22/2011		9/22/2012 Approved 1/25/2013
Takeda (Millennium)/Johnson & Johnson (Ortho Biotech Oncology) Velcade Bortezomib^a	Supplemental filing based on long-term overall survival data from the VISTA trial of Velcade in combination with melphalan and prednisone (VcMP) in patients with previously untreated multiple myeloma; earlier VISTA data was the basis for FDA's 6/2008 approval of Velcade for previously untreated MM patients	Announced 9/2/2009		7/2010 or earlier
West-Ward Pharmaceuticals Phenylephrine, inj.^a	Formal NDA filing for injectable formulation of the vasoconstrictor and pressor drug, previously available without FDA approval (sold by Baxter HealthCare, then acquired by West-Ward 5/2011), to increase blood pressure in acute hypotensive states, such as shock and peri-operative hypotension	1/12/2012	Advisory committee 9/13/2012 supported approval for peri-operative hypotension on an informal vote but voted 5-3 against approval for shock/acute hypotension	11/9/2012 (Standard review assigned) Approved 12/20/2012
Winston Civanex Zucapsaicin, 0.075% cream^b	Transient receptor potential vallinoid (TRPV-1) modulator, also known as civamide, that selectively depresses activity of type-C pain fibers for topical treatment of signs and symptoms of osteoarthritis of the knee as monotherapy or in combination with systemic pain relief medications	6/30/2010		4/30/2011
World Health Organization Artesunate rectal suppositories^b	Artemisinin derivative formulated as a single-dose rectal suppository for initial pre-referral treatment of patients with acute malaria who cannot take medication by mouth and who do not have access to parenteral treatment, to stabilize patients in remote locations for transportation to definitive treatment	11/24/2009 (Response to 5/15/2008 "approvable" letter; previously "approvable" 5/8/2007 (response submitted 11/12/2007) and 8/2/2002 (response submitted 11/4/2006). NDA initially submitted 9/24/2001 for accelerated approval.)	Advisory committee 4/29/2010 voted 13-2 in favor of approval for patients up to age 6 and 14-1 against approval in patients older than 6 years	5/24/2010
* Status as priority or standard review unknown ^a Submission for new use or new formulation of drug that sponsor already markets ^b New molecular entity or combination product with NME as component