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.

Sponsor & Product	Class/Indication	Submission/Receipt Date	Advisory Committee Status	Estimated User Fee Goal
Applications With User Fee Review Goals In November & December 2014 & January 2015
AbbVie ABT-450^b, ritonavir^a, ombitasvir^b and dasabuvir^b (ombitasvir is also known as ABT-267 and dasabuvir as ABT-333)	All-oral, interferon-free, direct-acting antiviral regimen comprising the protease inhibitor ABT-450, boosted with ritonavir, co-formulated with the NS5A inhibitor ombitasvir, dosed once daily, plus the non-nucleoside polymerase inhibitor dasabuvir, dosed twice daily with or without ritonavir, for treatment of adults with chronic genotype 1 hepatitis C virus (HCV) infection	4/21/2014 “Breakthrough therapy” designation awarded		12/22/2014 (Priority review assigned)
Actavis, AstraZeneca Ceftazidine and avibactam^b	Combination of the third-generation cephalosporin antibiotic and the novel beta-lactamase inhibitor for treatment of complicated urinary tract infections, including cUTI caused by multi-drug resistant gram-negative infections	Summer 2014 (FDA acceptance for filing announced 9/5/2014) (Submitted under 505(b)(2) pathway)		Q1 2015 (Priority review assigned)
Actavis (Forest Laboratories), Adamas Pharmaceuticals Memantine extended-release^a and donepezil	Fixed-dose combination of the extended-release formulation of the glutamate pathway modulator (Forest’s Namenda XR) and the immediate-release acetylcholinesterase inhibitor for treatment of moderate to severe dementia of the Alzheimer’s type	Announced 3/5/2014		1/5/2015 or earlier (Assuming standard review)
Actavis (Forest Laboratories) Nebivolol^a and valsartan	Fixed-dose combination of the cardioselective antihypertensive (Forest’s Bystolic) and the angiotensin II receptor blocker for treatment of hypertension	Announced 2/27/2014	Advisory committee 9/9/2014 voted 6-4 against approval	12/27/2014 or earlier (Assuming standard review)
Aeterna Zentaris Macrilen Macimorelin^b	Ghrelin agonist for oral administration to induce growth hormone release to evaluate adult growth hormone deficiency	11/5/2013		11/5/2014 (Standard review assigned) “Complete response” letter announced 11/6/2014
Amgen, Servier Ivabradine^b	Inhibitor of sinoatrial node I(f) current (“funny” current) for oral treatment of chronic heart failure	Summer 2014		Winter 2015 (Priority review assigned)
AstraZeneca Olaparib^b	Poly ADP-ribose polymerase (PARP) inhibitor for treatment of platinum-sensitive relapsed BRCA-mutated ovarian cancer	2/2014 (FDA accepted NDA 4/2014) (Submitted for accelerated approval)	Advisory committee 6/25/2014 voted 11-2 that approval should be delayed pending confirmatory Phase III data	1/3/2015 (Priority review assigned) (Goal date extended from 10/3/2014)
AstraZeneca Xigduo XR Dapagliflozin^a and metformin, extended-release	Fixed-dose combination of the sodium glucose co-transporter 2 (SGLT-2) inhibitor (approved as a single agent as Farxiga) and extended-release metformin for once-daily treatment of type 2 diabetes	Q4 2013		Q4 2014 (Assuming standard review) Approved 10/29/2014
Avanir, OptiNose AVP-825 Sumatriptan, intranasal powder	Low-dose powder formulation of the 5-HT1 agonist using OptiNose’s closed-palate Breath Powered intranasal delivery technology for acute treatment of migraine	1/27/2014 (Submitted under the 505(b)(2) pathway)		11/26/2014 (Standard review assigned) “Complete response” letter announced 11/26/2014
BioCryst Pharmaceuticals Rapivab Peramivir^b	Viral neuraminidase inhibitor for I.V. treatment of acute uncomplicated influenza in adults	Announced 12/20/2013		12/23/2014 (Standard review assigned) (FDA issued Form 483 to contract manufacturer, BioCryst said 5/8/2014; company is unsure of impact on review)
Boehringer Ingelheim, Lilly Empagliflozin^a and linagliptin^a	Fixed-dose combination formulation of the sodium glucose co-transporter 2 inhibitor (Jardiance) and the dipeptidyl peptidase-4 inhibitor (Tradjenta) for treatment of type 2 diabetes in adults	Q1 2014 (FDA acceptance of NDA announced 4/14/2014)		12/2014-1/2015 (Assuming standard review)
Boehringer Ingelheim Ofev Nintedanib^b	Tyrosine kinase inhibitor for treatment of idiopathic pulmonary fibrosis	5/2/2014 (Breakthrough therapy designation)		1/2/2015 (Priority review assigned) Approved 10/15/2014
Bristol-Myers Squibb Asunaprevir^b	NS3 protease inhibitor for use in combination with Bristol’s NS5A replication complex inhibitor daclatasvir for treatment of genotype 1b hepatitis C virus infection	Announced 4/7/2014 Breakthrough therapy designation for DCV+ASV regimen		11/30/2014 (Priority review assigned) Bristol announced withdrawal of NDA 10/7/2014
Bristol-Myers Squibb Daclatasvir^b	NS5A replication complex inhibitor for use in combination with Bristol’s NS3 protease inhibitor asunaprevir (the NDA for which has been withdrawn) for treatment of genotype 1b hepatitis C virus infection and in combination with other agents for multiple HCV genotypes	Announced 4/7/2014 Breakthrough therapy designation for DCV+ASV regimen		11/30/2014 (Priority review assigned) “Complete response” letter announced 11/26/2014
Clarus Therapeutics Rextoro Testosterone undecanoate (formerly CLR-610)	Oral testosterone prodrug as replacement therapy for treatment of low testosterone levels in men	1/3/2014	Advisory committee 9/18/2014 voted 18-3 that approval was not supported by benefit/risk	11/3/2014 (Standard review assigned)
Cubist Pharmaceuticals Ceftolozane^b and tazobactam	Combination of the novel cephalosporin antibiotic and the established beta-lactamase inhibitor for treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by Gram-negative bacteria	4/21/2014		12/21/2014 (Priority review assigned)
Daiichi Sankyo Savaysa Edoxaban^b	Direct Factor Xa inhibitor anticoagulant for once-daily oral use to reduce risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation, for treatment of deep vein thrombosis or pulmonary embolism, and for prevention of recurrence of symptomatic venous thromboembolism	Announced 1/8/2014	Advisory committee 10/30/2014 voted 9-1 in favor of approval for reduction in stroke and systemic embolism risk in NVAF patients	1/8/2015 or earlier (Assuming standard review)
Genentech Avastin Bevacizumab^a	New indication for the anti-vascular endothelial growth factor (VEGF) monclonal antibody for use in combination with paclitaxel for treatment of recurrent platinum-resistant ovarian, fallopian tube or peritoneal cancer patients who have received no more than two prior chemotherapy regimens	5/20/2014		11/19/2014 (Priority review assigned) Approved 11/14/2014
Johnson & Johnson (Janssen) Invega Sustenna Paliperidone palmitate^a	New indication for the once-monthly atypical antipsychotic formulation for treatment of schizoaffective disorder as monotherapy or adjunctive therapy	5/12/2014		11/12/2014 (if priority review); 3/12/2015 (if standard) Approved 11/12/2014
Impax Laboratories Rytary Carbidopa, extended-release and levodopa, extended-release (Also known as IPX066)	Next-generation extended-release oral capsule formulation of the combination therapy for treatment of idiopathic Parkinson’s disease	Announced 4/11/2014 (Class 2 resubmission after “complete response” letter announced 1/21/2013; NDA submitted 12/2011)		1/9/2015 (Goal date extended from 10/9/2014)
Incyte Jakafi Ruxolitinib^a	New indication for the JAK1 and JAK2 inhibitor for treatment of polycythemia vera patients who had inadequate response to or intolerant of hydroxyurea	6/5/2014 (FDA acceptance for review announced 8/5/2014)		12/5/2014 (Priority review assigned) Approved 12/4/2014
InterMune Esbriet Pirfenidone^b	Dual inhibitor of TGF-beta synthesis and TNG-alpha synthesis as an anti-fibrotic and anti-inflammatory agent to reduce declines in lung function in patients with idiopathic pulmonary fibrosis	5/23/2014 (Class 2 resubmission after 5/4/2010 “complete response” letter; originally submitted 11/4/2009) (Breakthrough therapy designation)		11/23/2014 (Priority review assigned) Approved 10/15/2014
Ipsen Somatuline Depot Lanreotide^a	New indication for the somatostatin analog depot injection for antiproliferative treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs)	Announced 7/1/2014		Early Q1 2015 (Priority review assigned)
Johnson & Johnson (Janssen), Medivir Olysio Simeprevir^a	New indication for the NS3/4A protease inhibitor for combination use with Gilead’s nucleotide polymerase inhibitor Sovaldi (sofosbuvir) for treatment of genotype 1 hepatitis C virus genotype 1 patients with advanced fibrosis who are treatment-naïve and for null-responders in all stages of liver fibrosis	5/6/2014		11/6/2014 (Assuming priority review) Approved 11/5/2014
Lundbeck LLC Carbella Carbamazepine	Intravenous formulation of the anti-epileptic drug for use as replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control seizures when oral carabamazepine administration is temporarily not feasible	Announced 3/10/2014		Late 2014 “Complete response” letter announced 10/24/2014
Merck Keytruda Pembrolizumab^b (formerly MK-3475, lambrolizumab)	Anti-Programmed Cell Death-1 (PD-1) antibody immune checkpoint modulator for treatment of unresectable or metastatic melanoma in patients previously treated with ipilimumab	2/28/2014 (BLA seeks accelerated approval; designated “breakthrough” therapy for advanced melanoma)		10/28/2014 (Priority review assigned) Approved 9/4/2014
Navidea Biopharmaceuticals Lymphoseek Technetium Tc 99m tilmanocept^a	Broader indication for the receptor-targeted small molecule radiopharmaceutical with more flexible utilization practices in lymphatic mapping and lymphoscintigraphic imaging	12/16/2014		10/16/2014 (Standard review assigned) Approved 10/14/2014
Novartis Signifor LAR Pasireotide^a (previously SOM230)	Long-acting release formulation of the somatostatin analog for once-monthly intramuscular injection for treatment of acromegaly	Q4 2013		Autumn 2014 (Assuming standard review)
NPS Pharmaceuticals Natpara Recombinant human parathyroid hormone 1-84^b	Recombinant human parathyroid hormone 1-84 (rhPTH[1-84]) as replacement therapy for endogenous PTH for long-term treatment of hypoparathyroidism	10/2013	Advisory committee 9/12/2014 voted 8-5 that approval was supported by risk/benefit	1/24/2015 (Standard review assigned) (Goal date extended from 10/24/2014)
Merck Gardasil 9 Vaccine, human papilloma virus (9-valent)^b (formerly V503)	Nine-valent human papilloma virus vaccine that adds HPV types 31, 33, 45, 52 and 58 to the four HPV types targeted by Merck’s Gardasil (HPV types 6, 11, 16 and 18 vaccine) for prevention of high-grade cervical, vaginal and vulvar disease (pre-cancers)	Late 2013		Late 2014 (Standard review assigned) Approved 12/20/2014
Novartis Farydak Panobinostat^b (also known as LBH589)	Pan-deacetylase (pan-DAC) inhibitor in combination with bortezomib and dexamethasone for treatment of relapsed or relapsed and refractory multiple myeloma	3/2014	Advisory committee 11/6/2014 voted 5-2 that benefit did not outweigh risk	11/24/2014 (Priority review assigned)
Novartis Secukinumab^b (previously AIN457)	Anti-interleukin 17 monoclonal antibody for treatment of moderate to severe plaque psoriasis	10/2013	Advisory committee 10/20/2014 unanimously voted to recommend approval	1/2015 (Goal date may have been extended from 10/2014, assuming standard review)
Octapharma AG Octanate Coagulation Factor VIII, von Willebrand Factor^b	Human plasma-derived coagulation Factor VIII stabilized with von Willebrand Factor to produce less inhibitor reaction than recombinant FVIII for treatment of hemophilia A	Late 2013		Late 2014
Pozen Yosprala 325/40 Aspirin 325 mg and omeprazole 40 mg (formerly PA32540)	Coordinated-delivery oral tablet with 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 7/1/2014 (Class 2 resubmission after 4/25/2014 “complete response” letter; NDA originally submitted 3/2013)		12/30/2014
Pozen Yosprala 81/40 Aspirin 81 mg and omeprazole 40 mg (formerly PA8140)	Coordinated-delivery oral tablet with 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	Announced 7/1/2014 (Class 2 resubmission after 4/25/2014 “complete response” letter; NDA originally submitted 3/2013)		12/30/2014
Purdue Pharma Hysingla ER Hydrocodone bitartrate	Singe-entity, extended-release opioid tablet formulated with abuse-deterrent technology for once-daily treatment of chronic pain	4/2014		Autumn 2014 (Priority review assigned) Approved 11/20/2014
Rockwell Medical Triferic Ferric pyrophosphate citrate	Soluble iron replacement drug delivered via dialysate during dialysis treatment for treatment of iron deficiency and to maintain hemoglobin in adults with hemodialysis-dependent Stage 5 chronic kidney disease (CKD 5HD)	Announced 3/24/2014	Advisory committee 11/6/2014 voted 8-3 in favor of approval	1/24/2015 (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 to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations	4/15/2014 and 5/14/2014 (Submissions constituted full response to 12/27/2013 “complete response” letter; sBLA originally submitted 11/27/2012)		11/14/2014 Approved 11/14/2014
Sanofi Toujeo Insulin glargine, recombinant (formerly U300)	Basal insulin formulated to be more concentrated and have a flatter, more prolonged PK/PD profile than Sanofi’s Lantus (insulin glargine)	Announced 6/16/2014 (FDA acceptance of NDA for filing announced 7/8/2014)		H1 2015
Teva QNASL Beclomethasone^a	Low-dose formulation of the waterless HFA corticosteroid nasal aerosol to extend use to pediatric patients aged 4 to 11 years old for treatment of seasonal and allergic rhinitis	Spring 2014 (FDA acceptance of sNDA announced 5/13/2014)		Q1 2015 (Assuming standard review)
The Medicines Company Raplixa Fibrinogen, thrombin (formerly Fibrocaps)	Dry powder formulation of the hemostatic agents to aid in hemostasis during surgery when control of mild or moderate bleeding by conventional means is ineffective or impractical	3/2014		1/31/2015 (Standard review assigned)
Vertex Pharmaceuticals Kalydeco Ivacaftor^a	Expanded indication for the cystic fibrosis transmembrane conductance regulator (CFTR) potentiator for treatment of cystic fibrosis patients ages six and older who have the R117H mutation in the CFTR gene	6/30/2014 (sNDA initially submitted for adults, amended 8/19/2014 to include patients six years of age and older)	Advisory committee 10/21/2014 voted 13-2 to recommend approval in patients aged six and older	12/30/2014 (Priority review assigned)
Zogenix Zohydro ER Hydrocodone, extended-release^a	New abuse-deterrent formulation of the extended-release opioid agonist incorporating inactive ingredients to make abuse by injection or nasal insufflation more difficult, for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate	Announced 10/1/2014		Q1 2015 (Assuming priority review)
Recently Announced NDA And BLA Submissions
Amgen Talimogene laherparepvec^b	Oncolytic immunotherapy derived from HSV-1 for treatment of regionally or distantly metastatic melanoma	7/2014		7/28/2015 (Standard review assigned)
AstraZeneca Iressa Gefitinib	EGFR tyrosine kinase inhibitor as targeted monotherapy for first-line treatment of patients with advanced or metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer, as identified through a companion diagnostic test	Announced 12/2/2014 (Original accelerated approval granted in 2003, but use limited after confirmatory trial failure in 2005 and withdrawn in 2011)		Q3 2015
Baxter/Nektar BAX 855 Factor VIII, recombinant^b	Extended half-life recombinant factor VIII (rFVIII) based on Baxter’s antihemophilic factor Advate formulated with Nektar’s PEGylation technology for treatment of hemophilia A	Announced 12/1/2014		12/1/2015 or earlier (Assuming standard review)
Pfizer Prevnar 13 Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)^a	Expanded efficacy data for the pneumococcal vaccine regarding use in older adults for prevention of pneumococcal pneumonia and invasive disease caused by Streptococcus pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F	H2 2014 (Fulfillment of commitment under accelerated approval program)		5/2015
Ipsen Dysport AbobotulinumtoxinA^a	Botulinum toxin type A for treatment of upper limb spasticity in adults	9/2014-10/2014 (FDA acceptance of sBLA announced 11/28/2014)		7/2015-8/2015 (if standard review); 3/2015-4/2015 (if priority)
Johnson & Johnson (Janssen)/PharmaMar Yondelis Trabectedin^b	DNA minor groove binder for treatment of patients with soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline	Announced 11/24/2014 Previous NDA for ovarian cancer withdrawn after 9/2009 “complete response” letter		11/24/2015 or earlier (if standard review); 7/24/2015 or earlier (if priority)
Regeneron Eylea Aflibercept^a	Vascular endothelial growth factor inhibitor for treatment of diabetic retinopathy in patients with diabetic macular edema	Summer 2014 “Breakthrough” therapy designation		3/30/2015 (Priority review assigned)
Sunovion Aptiom Eslicarbazepine^a	Expanded indication for the voltage-gated sodium channel inhibitor for monotherapy of partial-onset seizures	Announced 12/5/2014		10/5/2014 or earlier (Assuming standard review)
Synageva Sebelipase alfa^b	Recombinant lysosomal acid lipase as enzyme replacement therapy for lysosomal acid lipase deficiency in patients from infants to adults	Announced 12/2/2014 “Breakthrough” therapy designation for LAL deficiency in infants		8/2/2014 or earlier (Assuming priority review)
Applications With User Fee Goals In February 2015 And Beyond
Actavis (Furiex) Eluxadoline^b	Mu opioid receptor agonist and delta opioid receptor antagonist for treatment of diarrhea and abdominal pain in men and women with diarrhea-predominant irritable bowel syndrome (IBS-D)	Summer 2014 (FDA acceptance of NDA announced 9/2/2014)		Q2 2015 (Priority review assigned; goal date includes predicted extension due to planned submission of data from study ongoing at time of submission)
Actavis, Medicines360 Levosert Levonorgestrel	Hormonal intrauterine contraceptive (IUC) for prevention of pregnancy	4/2014 (FDA acceptance for filing announced 6/21/2014)		2/28/2015 (Standard review assigned)
Adamis Pharmaceuticals Epinephrine	Pre-filled single-dose syringe formulation of adrenaline for emergency treatment of Type I allergic reactions including anaphylaxis	Announced 5/29/2014 (Submitted under the 505(b)(2) pathway)		3/29/2015 or earlier (Assuming standard review)
Alkermes Aripiprazole lauroxil^b	Depot injection formulation of the atypical antipsychotic (Otsuka’s Abilify) using Alkermes’ LinkeRx technology for once-monthly treatment of schizophrenia	Announced 8/25/2014 (Submitted under 505(b)(2) pathway, but Otsuka petitioned for review as an NME)		8/22/2015 (Standard review assigned)
Amgen Blinatumomab^b	Bispecific T-cell engager (BiTE) antibody construct that targets CD19 for treatment of adults with Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukemia	Announced 9/22/2014 (“Breakthrough” therapy status awarded)		5/19/2015 (Priority review assigned)
Amgen Evolocumab^b	Monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) for treatment of high LDL cholesterol	8/27/2014		8/27/2015 (Standard review assigned)
Astellas, Basilea Isavuconazole^b	Broad-spectrum azole antifungal in oral and I.V. formulations for treatment of invasive aspergillosis and invasive mucormycosis, fungal infections predominantly seen in immunocompromised patients	Announced 7/9/2014		3/8/2015 (Priority review assigned)
Avedro Riboflavin	Ophthalmic solution formulation of vitamin B2 for use in Avedro’s KXL System for corneal collagen cross-linking procedures, which combine UV light and riboflavin eye drops, for treatment of progressive keratoconus or corneal ectasia following refractive surgery	Announced 9/30/2014 (Resubmission after 3/2014 “complete response” letter; NDA originally submitted 9/2013)		3/2015 (Priority review assigned)
Boehringer Ingelheim, Lilly Empagliflozin^a and metformin	Fixed-dose combination formulation of the sodium glucose co-transporter 2 inhibitor Jardiance and immediate-release metformin for treatment of type 2 diabetes	Late summer 2014 (FDA acceptance of NDA for filing announced 10/21/2014)		6/2015-7/2015 (Assuming standard review)
Boehringer Ingelheim Olodaterol^a and tiotropium^a	Fixed-dose combination of the long-acting beta agonist (BI’s Striverdi) and the long-acting muscarinic antagonist (BI’s Spiriva) formulated for use with BI’s propellant-free Respimat inhaler for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema	Mid-2014 (FDA acceptance for review announced 8/19/2014)		4/2015-5/2015 (Assuming standard review)
Bristol-Myers Squibb Atazanavir^a and cobicistat^a	Once-daily oral fixed-dose combination formulation of the protease inhibitor (Bristol’s Reyataz) and Gilead Sciences’ pharmokinetic enhancer (a component of Stribild) for use in combination with other antiretrovirals for treatment of HIV-1 infection	4/4/2014		2/4/2015 (Assuming standard review)
Bristol-Myers Squibb Opdivo Nivolumab^b	Programmed death-1 (PD-1) immune checkpoint inhibitor for treatment of patients with previously treated advanced melanoma	7/2014 (“Breakthrough” therapy designation)		3/30/2015 (Priority review assigned)
Celltrion Remsima Infliximab	Biosimilar version of the anti-tumor necrosis factor (TNF) alpha monoclonal antibody (Johnson & Johnson’s Remicade) for treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriasis and psoriatic arthritis	8/8/2014 (Filed under the 351(k) pathway)		6/8/2015
Eisai Banzel Rufinamide^a	Expanded pediatric indication for the antiepileptic drug for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children aged one to four years old	Late summer 2014 (FDA acceptance of sNDA for review announced 10/15/2014)		4/2015-5/2015 (Priority review assigned)
Eisai Fycompa Perampanel^a	New indication for the AMPA receptor antagonist for adjunctive treatment of primary generalized tonic-clonic seizures	8/19/2014		6/20/2015 (Assuming standard review)
Eisai Lenvatinib^b	Multiple receptor tyrosine kinase (RTK) inhibitor for oral treatment of progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC)	Announced 8/18/2014		4/18/2015 or earlier (Priority review assigned)
Emergent BioSolutions BioThrax Anthrax vaccine, adsorbed^a	New indication for the anthrax vaccine for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure when combined with the recommended course of antimicrobials in persons 18 through 65 years of age	Announced 11/10/2014		5/10/2015 or earlier (Assuming priority review)
Genentech Lucentis Ranibizumab^a	New indication for the vascular endothelial growth factor (VEGF) inhibitor for treatment of diabetic retinopathy	8/7/2014		2/6/2015 (Priority review assigned)
Gilead Sciences Elvitegravir^a, cobicistat^a, emtricitabine^a and tenofovir alafenamide (also known as E/C/F/TAF)	Combination of the integrase strand transfer inhibitor (Gilead’s Vitekta), CYP3A inhibitor (Gilead’s Tybost), nucleoside analog reverse transcriptase inhibitor (Gilead’s Emtriva) and the prodrug of Gilead’s Viread, which is more effective at a lower dose, for treatment of HIV infection in treatment-naïve patients as well as those who are virologically suppressed and switching therapy	Announced 11/6/2014		9/6/2015 or earlier (Assuming standard review)
GlaxoSmithKline, Theravance Breo Fluticasone and vilanterol^a	New indication for the fixed-dose combination of the corticosteroid and the long-acting beta2 agonist (LABA) for inhalation using the Ellipta dry powder inhaler for once-daily treatment of asthma in patients aged 12 years and older	6/30/2014		4/30/2015 (Assuming standard review)
GlaxoSmithKline Mepolizumab^b	Anti-interleukin-5 monoclonal antibody for add-on maintenance treatment of severe eosinophilic asthma in patients ages 12 years and older with a history of exacerbations	Announced 11/5/2014		7/5/2015 or earlier (if priority review); 11/5/2015 or earlier (if standard)
Insys Therapeutics Dronabinol	Oral solution formulation of the synthetic cannabinoid, available generically in soft gel capsules, for treatment of anorexia associated with weight loss in AIDS patients and chemotherapy-induced nausea and vomiting in cancer patients who failed to respond adequately to conventional antiemetics	Announced 8/12/2014		6/12/2015 or earlier (Assuming standard review)
Johnson & Johnson (Janssen) Darunavir^a and cobicistat^a	Fixed-dose combination formulation of the protease inhibitor (J&J’s Prezista) with Gilead’s pharmacokinetic enhancer (a component of Stribild) for treatment of HIV infection	4/1/2014		2/1/2015 (Assuming standard review)
Johnson & Johnson (Janssen) Invega Sustenna Paliperidone palmitate^a	New claim for the once-monthly atypical antipsychotic based on the “real-world” PRIDE trial showing significantly delayed time to relapse of schizophrenia compared with oral antipsychotics	Announced 7/14/2014		5/14/2015 or earlier
Johnson & Johnson (Janssen) Paliperidone palmitate^a	New three-month depot formulation of the atypical antipsychotic (approved in a one-month formulation as Invega Sustenna) for treatment of schizophrenia in adults	Announced 11/19/2014		9/19/2015 or earlier (Assuming standard review)
Kythera Biopharmaceuticals ATX-101 Deoxycholic acid	Injectable formulation of a purified synthetic version of naturally occurring deoxycholic acid for reduction of submental fat	Announced 5/12/2014		2/2015 or earlier (if standard review); 11/2014 or earlier (if priority)
Mallinckrodt MNK-155 Hydrocodone, extended-release and acetaminophen, extended-release	Extended-release oral formulation of the opioid and acetaminophen using Mallinckrodt technology and Depomed’s Acuform delivery technology for management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate	Announced 5/28/2014		3/28/2015 or earlier
Merck MK-0518B Raltegravir^a and lamivudine	Fixed-dose combination of a new formulation of the integrase inhibitor (Isentress) with the nucleoside analog for use in combination with other antiretrovirals for treatment of HIV-1 infection in adults, adolescents, and pediatric patients (aged 6-16 years and weighing at least 30 kg)	Announced 6/24/2014		3/24/2015 or earlier (Standard review assigned)
Merck, Sanofi Pasteur Vaccine, hexavalent (DTaP5-IPV-Hib-HepB)^b	Pediatric hexavalent vaccine to protect against diphtheria, tetanus, pertussis, polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type B (Hib), and hepatitis B	Late summer 2014 (FDA acceptance of BLA announced 10/20/2014)		8/2015-9/2015 (Assuming standard review)
Newron Pharmaceuticals, Zambon S.p.A. Safinamide^b	Alpha-aminoamide for add-on therapy to a stable dose of a single dopamine agonist in early Parkinson’s disease and in combination regimens for mid- to late-stage Parkinson’s	5/29/2014 (FDA refuse to file action announced 7/29/2014)		5/29/2015 (if standard review); 1/29/2015 (if priority)
Novartis Sonidegib^b (also known as LDE225)	Selective smoothened (SMO) inhibitor that acts on the hedgehog signaling pathway for oral treatment of advanced basal cell carcinoma	Q3 2014		Q2 2015 (if priority review); Q3 2015 (if standard)
Orexo AB Zubsolv Buprenorphine and naloxone^a	Expanded indication for the partial opioid agonist to include initiation of treatment for opioid dependence	Announced 10/13/2014		6/13/2015 or earlier (Assuming standard review)
Otsuka, Lundbeck Brexpiprazole^b	Serotonin-dopamine activity modulator (SDAM) for monotherapy treatment of schizophrenia and adjunct treatment of major depressive disorder	Announced 7/14/2014		7/11/2015 (Standard review assigned)
Pfizer Trumenba Vaccine, meningococcal B (bivalent recombinant LP2086)	Vaccine containing two recombinant versions of factor H binding protein (the LP2086 antigen) for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25 year olds	Announced 6/17/2014 “Breakthrough” therapy designation awarded		2/14/2015 (Priority review assigned) Accelerated approval granted 10/29/2014
Pfizer Palbociclib^b	Cyclin-dependent kinase (CDK) 4 and 6 inhibitor for use in combination with letrozole for oral treatment of postmenopausal women with estrogen receptor-positive (ER+), epidermal growth factor receptor 2-negative (HER2-) breast cancer who have not received systemic therapy for advanced disease	8/2014 (Completion of rolling submission announced 8/18/2014) (“Breakthrough therapy” designation)		4/13/2015 (Priority review assigned)
Pharmacyclics, Johnson & Johnson (Janssen) Imbruvica Ibrutinib^a	New indication for the Bruton’s tyrosine kinase (BTK) inhibitor for treatment of patients with Waldenstrom’s macroglobulinemia, a rare type of B-cell lymphoma	Announced 10/20/2014 (“Breakthrough” therapy designation)		4/20/2015 or earlier (Assuming priority review)
Relypsa Patiromer^b	High capacity potassium binder formulated as an oral suspension for treatment of hyperkalemia	Announced 10/22/2014		6/22/2015 or earlier (if priority review); 10/22/2015 or earlier (if standard)
Salix Pharmaceuticals Xifaxan Rifaximin, 550 mg tabs.^a	New indication for the high-dose tablet formulation of the gut-selective antibiotic for treatment of non-constipation or diarrhea-predominant irritable bowel syndrome and IBS-related bloating	8/29/2014 (Full response to FDA’s 3/7/2011 “complete response” letter; originally submitted 6/2010)		2/28/2015 (Priority review assigned)
Sandoz (Novartis) Filgrastim (formerly Zarzio)	Biosimilar version of Amgen’s granulocyte-colony stimulating factor Neupogen for use in cancer patients receiving myelosuppressive chemotherapy; acute myeloid leukemia patients receiving induction or consolidation chemotherapy; cancer patients receiving bone marrow transplant; patients undergoing peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia	5/2014 (FDA acceptance of filing announced 7/24/2014) (Submitted under the 351(k) pathway for biosimilars) (Amgen filed suit to block review of biosimilar application on 10/24/2014)	Advisory committee review scheduled for 1/7/2015	3/2015 (Standard review assigned)
Shire Vyvanse Lisdexamfetamine^a	New indication for the amphetamine compound for treatment of adults with binge eating disorder	8/2014		2/2015 (Priority review assigned)
Spriaso/NexGen Rinotuss12 Codeine and chlorpheniramine	Solid oral fixed-dose combination formulation of the narcotic antitussive and antihistamine for treatment of cough and cold	Autumn 2014 (FDA acceptance of NDA announced 11/6/2014)		Summer 2015 (Assuming standard review)
Tesaro/OPKO Health Rolapitant^b	Neurokinin-1 (NK-1) receptor antagonist for prevention of chemotherapy-induced nausea and vomiting (CINV)	Announced 9/8/2014		9/8/2015 or earlier (Assuming standard review)
Teva Albuterol	Short-acting beta agonist formulated for use with a breath-actuated dry powder inhaler (DPI) for treatment and prevention of bronchospasm in patients 12 years and older with reversible obstructive airway disease and to prevent exercise-induced bronchospasm	5/2014 (FDA acceptance for filing announced 7/14/2014)		3/2015 (Standard review assigned)
Tris Pharma/Vernalis Tuzistra XR (also known as CCP-01)	Extended-release formulation of an existing immediate-release prescription product for acute treatment of cough and cold	Summer 2014 (FDA acceptance of NDA announced 9/15/2014)		4/30/2015
Vertex Pharmaceuticals Lumacaftor^band ivacaftor^a	Co-formulated combination of the cystic fibrosis transmembrane conductance regulator (CFTR) corrector, which addresses processing and trafficking defects in the F508del CFTR protein, and the CFTR potentiator (Vertex’ Kalydeco) for treatment of cystic fibrosis patients ages 12 and older who have two copies of the F508del mutation	Announced 11/5/2014 (“Breakthrough” therapy status awarded)		7/5/2015 or earlier (Assuming priority review)
Applications Past Original User Fee Goals
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	Advisory committee 10/16/2013 voted 9-2 against approval	12/20/2013 (Standard review assigned) (Amarin announced 9/12/2014 that FDA’s Office of New Drugs rejected Amarin’s formal dispute resolution appeal seeking to reinstate the ANCHOR trial SPA, which FDA rescinded 10/2013; “complete response” letter expected)
Astellas Pharma Tacrolimus^a, extended-release	Once-daily oral capsule 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 Approved for kidney transplants only 7/19/2013 as Astragraf XL
AstraZeneca Nexium Esomeprazole^a	New claim for the proton pump inhibitor for reduction in risk of peptic ulcers associated with low-dose aspirin and for reduced risk of peptic ulcer bleeding	12/2012 (Response to 6/2011 “complete response” letter; first action letter announced 6/1/2010; sNDA originally submitted 5/29/2008)		6/2013 Approved 3/4/2014 to reduce risk of rebleeding of gastric or duodenal ulcers following endoscopy
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)
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 Saxenda Liraglutide^a	Higher dose of the human glucagon-like peptide (GLP-1) analog (3 mg once-daily vs. the 1.2 and 1.8 mg once-daily doses approved for diabetes as Victoza) as an adjunct to diet and exercise for chronic weight management in adults with obesity or who are overweight with comorbidities	12/20/2013	Advisory committee 9/11/2014 voted 14-1 in favor of approval	10/20/2014 (Standard review assigned)
Pfizer, Octapharma Human prothrombin complex concentrate^b (Octaplex outside U.S.)	Human prothrombin complex concentrate for urgent reversal of Vitamin K antagonist (e.g. warfarin) anticoagulant treatment in adults who require urgent surgery or invasive procedures	4/2013		4/2014 (Assuming standard review)
Red Hill Biopharma, IntelGenx Rizaport Rizatriptan, oral film (also known as RHB-103)	Orally disintegrating polymeric film formulation of the 5-HT1 receptor antagonist using IntelGenx’ VersaFilm technology that is bioequivalent to Merck’s Maxalt MLT (rizatriptan orally disintegrating tablets) for treatment of migraine	Announced 3/3/2014 (Resubmission following “complete response” letter announced 2/4/2014; NDA originally submitted 3/27/2013 under 505(b)(2) pathway)		9/3/2014 or earlier (Red Hill said 9/22/2014 that approval remains contingent on resolving CMC questions and securing a compliant source of raw materials)
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 (16-cycle limit removed 7/2013, but FDA said retreatment claim will not be approved)
Teva Pharmaceuticals LeCette Desogestrel and ethinyl estradiol	Oral contraceptive with a 28-day regimen comprising 21 days of desogestrel, ethinyl estradiol follwed by 7 days of EE alone	9/2013		7/2014
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, for standard review) Teva is reviewing its U.S. long-acting G-CSF strategy
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
^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