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 April, May & June 2013

Alcon (Novartis) Simbrinza 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 elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

6/19/2012

4/19/2013 (assuming standard review) Approved 4/19/2013

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 “Complete response” letter announced 4/16/2013

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) Approved 5/14/2013

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

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 5/2/2013 voted 16-0 against approval

6/15/2013 (Priority review denied)

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.”

Endo (formerly Indevus)/Bayer (formerly Schering AG) Aveed Testosterone undeconate (formerly Nebido)

Long-acting oil-based depot intramuscular injection formulation of testosterone for replacement therapy in adult men with conditions associated with deficient or absent testosterone (male hypogonadism)

11/2012 (Response to 12/2/2009 “complete response” letter; previously “approvable” 2008; NDA originally submitted 2007)

Advisory committee 4/18/2013 voted 9-9 that safety acceptable but 17-1 that risk mitigation plans are insufficient

5/2013

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) “Complete response” letter announced 4/29/2013

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) “Complete response” letter announced 4/29/2013

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 4/17/2013 voted 9-4 to support maintenance approval and 9-4 to support exacerbation use (later revised to 8-5)

5/13/2013 Approved 5/10/2013

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 (assuming standard review)

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

4/15/2013 or earlier (if FDA extended goal from 1/5/2013 or earlier) “Complete response” letter announced 3/25/2013

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

6/3/2013 (Standard review assigned) Goal date extended to 9/3/2013

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

10/29/2012 (Full response to 11/15/2011 “complete response” letter; originally submitted 10/15/2010) Submitted under 505(b)(2) pathway

4/29/2013 Tentatively approved 4/29/2013

Johnson & Johnson (Janssen Ortho Biotech) 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 or who require continuous steroid therapy

7/2012

5/2013 Approved 5/15/2013

Merck Liptruzet Ezetimibe/atorvastatin^a (formerly Atozet and MK-0653C)

Fixed-dose combination of the intestinal cholesterol absorption inhibitor and the statin for treatment of primary or mixed hyperlipidemia

11/5/2012 (Full response to 2/29/2012 “complete response” letter; originally submitted 9/2/2009) (Submitted under the 505(b)(2) pathway)

5/5/2013 Approved 5/3/2013

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)

Advisory committee review scheduled for 7/18/2013

Late Spring 2013 (Priority review assigned) (Goal date extended to late summer 2013)

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 Ilaris Canakinumab^a

New indication for the interleukin-1 beta blocker for treatment of systemic juvenile idiopathic arthritis

11/7/2012

5/7/2013 Approved 5/9/2013

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

11/27/2012 (Response to 10/19/2012 “complete response” letter; originally submitted 12/21/2011)

Advisory committee 9/5/2012 voted 13-1 that safety and efficacy had been shown

5/27/2013 Approved 3/22/2013

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

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 treatment of the orphan lysosomal storage disease nephropathic cystinosis in adults and children six years and older

3/30/2012 (Submitted under 505(b)(2) pathway)

4/30/2013 (Priority review denied) (Goal date extended from 1/30/2013) Approved 4/30/2013

Roche Actemra Tocilizumab^a

New claim for the interleukin-6 receptor inhibitor for treatment of polyarticular-course juvenile idiopathic arthritis

6/29/2012

4/29/2013 (assuming standard review) Approved 4/29/2013

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

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

7/20/2012

4/22/2013 (Priority review granted) (Goal date extended from 1/2013) Approved 4/19/2013

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 3/21/2013 voted 10-4 (one abstention) to recommend approval

4/30/2013 (Priority review granted) “Complete response” letter announced 4/30/2013

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)

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

Recently Announced NDA/BLA Submissions

Celgene Abraxane Paclitaxel, protein-bound particles^a

New indication for the solvent-free, albumin-bound taxane formulation in combination with gemcitabine for treatment of treatment-naïve metastatic pancreatic cancer patients

3/2013

Q4 2013

Celgene Apremilast^b

Phosphodiesterase-4 inhibitor for treatment of adult patients with active psoriatic arthritis

3/2013

3/2014 (assuming standard review)

Celgene Revlimid Lenalidomide^a

New indication for the oral immunomodulatory drug for treatment of relapsed and refractory mantle cell lymphoma after prior therapy that included bortezomib

12/2012

6/5/2013 (Priority review granted)

Genentech (Roche) Obinutuzumab^b (also known as GA101)

Glycoengineered type II anti-CD20 monoclonal antibody modified with GlycoMAb technology for use in combination with chlorambucil for treatment of previously untreated chronic lymphocytic leukemia patients with co-existing medical conditions (co-morbidities)

Announced 5/15/2013

1/15/2014 or earlier (if priority review); 5/15/2014 or earlier (if standard)

Pharming/Santarus Ruconest Human C1 esterase inhibitor, recombinant^b

Recombinant version of the human protein C1 esterase inhibitor produced with Pharming’s transgenic technology for intravenous treatment of acute angioedema attacks in patients with hereditary angioedema

Announced 4/17/2013 (Previous BLA submission received “refuse to file” letter 2/2011)

4/17/2014 or earlier

Trimel Pharmaceuticals CompleoTRT Testosterone, intranasal

Bioadhesive intrasal gel formulation of testosterone with “no touch” targeted delivery to avoid skin-to-skin transference for treatment of testosterone deficiency in men

Annnounced 4/30/3013

3/3/2014 or earlier (Standard review expected)

Applications With User Fee Goals In July 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)

Alimera Sciences/pSivida Iluvien Fluocinolone acetonide, intravitreal insert^a

Extended-release intravitreal insert formulation of the corticosteroid that delivers sub-microgram levels of drug for up to 36 months for treatment of chronic diabetic macular edema (originally submitted for treatment of DME)

Announced 4/1/2013 (Resubmission after “complete response” letter announced 11/11/2011; previous CRL received 12/2010)

10/1/2013 or earlier (if Class 2 resubmission); 6/1/2013 or earlier (if Class 1)

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)

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)

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

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 5/2/2013 voted 13-1 that the risk/benefit profile was not favorable

7/28/2013

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)

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

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 (Priority review assigned)

Bayer/Algeta Xofigo Radium Ra 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) Approved 5/15/2013

Biogen Idec/Swedish Orphan Biovitrum Alprolix 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)

Biogen Idec/Swedish Orphan Biovitrum Eloctate Factor VIII Fc fusion protein, recombinant^b

Long-acting recombinant clotting factor formulation of Factor VIII using Biogen Idec’s monomeric Fc fusion technology to prolong circulating half-life for once- or twice-weekly injection for treatment of hemophilia A

Announced 3/12/2013

3/12/2014 or earlier (Standard review assigned)

BioMarin Vimizim Elosulfase alfa^b (also known as BMN-110)

Enzyme replacement therapy addressing deficient activity of N-acetylgalactosamine-6-sulfatase (GALNS) for treatment of the lysosomal storage disease Mucopolysaccharidosis Type IVA (MPS IVA, also called Morquio A Syndrome)

Announced 4/1/2013

12/1/2013 or earlier (if priority review); 4/1/2014 or earlier (if standard)

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 submitted a PMA for a companion diagnostic, the therascreen EGFR RGQ PCR kit

7/2013 (Priority review assigned)

Boehringer Ingelheim/Lilly Empagliflozin^b

Sodium glucose co-transporter 2 inhibitor for treatment of type 2 diabetes in adults

Announced 3/25/2013

3/25/2014 or earlier (assuming standard review)

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

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)

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)

Gilead Sciences Sofosbuvir^b

Oral nucleotide analog inhibitor of HCV NS5B protein for once-daily treatment of chronic hepatitis C virus infection in combination with ribavirin as all-oral therapy for patients with genotype 2 and 3 HCV infection and in combination with ribavirin and pegylated interferon for use in treatment-naïve patients with genotype 1,4, 5 and 6 HCV infection

Announced 4/8/2013

12/8/2013 or earlier (if priority review); 4/8/2014 or earlier (if standard)

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 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)

IntelGenx/Red Hill Biopharma Rizatriptan, oral film

Orally disintegrating polymeric film formulation of the triptan using IntelGenx’ VersaFilm technology that is bioequivalent to Merck’s Maxalt MLT (rizatriptan orally disintegrating tablets) for treatment of migraine

3/27/2013 Submitted under 505(b)(2) pathway

1/27/2014 (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)/Medivir Simeprevir^b (formerly TMC435)

NS3/4A protease inhibitor for once-daily oral use in combination with pegylated interferon and ribavirin for treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease

Announced 3/28/2013

11/28/2013 or earlier (Priority review assigned)

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)

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)

7/7/2013 or earlier (if standard review); 3/7/2013 or earlier (if priority)

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-3641 Allergy immunotherapy sublingual tablet (AIT), ragweed pollen^b

Dissolvable oral immunotherapeutic biologic to prevent allergy symptoms by inducing protective immune response against allergies for treatment of ragweed (Ambrosia artemisiifolia) pollen-induced allergic symptoms

3/2013

3/2014 (if standard review); 11/2013 (if priority review)

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 Timothy grass (Phleum pratense) pollen-induced allergic rhinoconjunctivitis

1/2013

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)

Advisory committee review scheduled for 5/22/2013

7/2013-11/2013 (Standard review assigned; 12-month user fee goal applies if submitted 10/1/2012 or later)

Neos Therapeutics Amphetamine polistirex, orally disintegrating tab.

Extended-release amphetamine formulation delivered in an orally disintegrating tablet using Neos’ Rapidly Disintegrating Ionic Masking (RDIM) technology for treatment of attention-deficit/hyperactivity disorder

12/28/2012 (Submitted under the 505(b)(2) pathway)

10/28/2013

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)

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

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)

Pozen PA32540 Aspirin 325 mg/ omeprazole 40 mg

Coordinated-delivery oral tablet combining an immediate-release proton pump inhibitor layered around a pH-sensitive coating of a high-dose aspirin core for once-daily use for secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers

Announced 3/27/2013

1/2014 or earlier (assuming standard review)

Pozen PA8140 Aspirin 81 mg/ omeprazole 40 mg

Coordinated-delivery oral tablet combining an immediate-release proton pump inhibitor layered around a pH-sensitive coating of a low-dose aspirin core for once-daily use for secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers

1/2014 or earlier (assuming standard review)

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)

8/26/2013

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

11/2012 (Original 6/2012 sBLA received refuse-to-file letter 8/2012)

11/2013 (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)

Seattle Genetics Adcetris Brentuximab vedotin^a

Expanded use of the antibody-drug conjugate of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to the microtubule disrupting agent monomethyl auristatin E for new claims for retreatment and use beyond the approved 16 cycles of therapy for treatment of relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma

Announced 3/18/2013

9/14/2013 (Priority review assigned)

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 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

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

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)

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)

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)

Applications Past Original User Fee Goals

Agile Therapeutics Twirla Ethinyl estradiol/levonorgestrel, transdermal (formerly AG200-15)

Once-weekly low-dose combination hormonal contraceptive patch for three weeks of use followed by one week off, formulated with Agile’s Skinfusion active and peripheral adhesive system, for prevention of pregnancy

Q2 2012

Q1 2013

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

3/12/2012

1/12/2013 Approved 4/12/2013 for recurrent herpes labialis

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 (1 abstention) that efficacy and safety were shown

3/2013

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

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

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)

* 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