May 3, 2016 - 02/26/16. Apple Tree Partners. Probuphine. Drug Addiction. NDA. 85% (2% Above Avg.) 02/26/16. Sarepta Ther
2016 PDUFA dates Expected Date Range
Company
Drug
Indication
Phase
Likelihood of Approval
01/15/16
Heron Therapeutics, Inc.
Sustol
Chemotherapy Induced Nausea and Vomiting (CINV)
NDA
83% (1% Above Avg.)
01/21/16
Novartis AG
Arzerra (Oncology)
Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL
Approved
100% (Same As Avg.)
01/22/16
Amgen, Inc.
Kyprolis
Multiple Myeloma (MM)
Approved
100% (Same As Avg.)
01/22/16
Bristol-Myers Squibb Company
Opdivo
Melanoma
Approved
100% (Same As Avg.)
01/27/16
Adapt Pharma Limited
Narcan
Drug Addiction
NDA
83% (Same As Avg.)
01/27/16
Neos Therapeutics, Inc.
NT0202
Attention Deficit Hyperactivity Disorder (ADHD)
NDA
85% (Same As Avg.)
01/28/16
Merck & Co., Inc.
Elbasvir/Grazoprevir FDC
Hepatitis C (HCV) (Antiviral)
NDA
92% (4% Above Avg.)
01/29/16
Eisai Co., Ltd.
Halaven
Sarcoma
NDA
87% (5% Above Avg.)
02/05/16
Dr. Reddy’s Laboratories
DFD-01
Psoriasis
NDA
87% (Same As Avg.)
02/05/16
Dr. Reddy’s Laboratories
DFD-09
Rosacea
NDA
89% (Same As Avg.)
02/05/16
Dr. Reddy’s Laboratories
DFN-11
Migraine and Other Headaches
NDA
83% (Same As Avg.)
02/05/16
Vertex Pharmaceuticals Incorporated
Kalydeco
Cystic Fibrosis (CF)
Approved
100% (Same As Avg.)
02/26/16
Apple Tree Partners
Probuphine
Drug Addiction
NDA
85% (2% Above Avg.)
02/26/16
Sarepta Therapeutics, Inc.
Eteplirsen
Muscular Dystrophy
NDA
92% (3% Above Avg.)
02/26/16
Telesta Therapeutics Inc.
MCNA
Bladder Cancer
BLA
82% (Same As Avg.)
02/29/16
Intercept Pharmaceuticals, Inc.
INT-747
Primary Biliary Cirrhosis (PBC) and Hepatic Fibrosis
NDA
97% (10% Above Avg.)
03/01/16
Advanced Accelerator Applications SA
Somakit
Neuroendocrine Tumors (NET) - Imaging
NDA
82% (Same As Avg.)
03/01/16
Gilead Sciences, Inc.
TAF/emtricitabine/rilpivirine
HIV / AIDS
NDA
88% (Same As Avg.)
03/04/16
Roche Holding AG
Alectinib
Non-Small Cell Lung Cancer (NSCLC)
NDA
87% (5% Above Avg.)
03/09/16
Johnson & Johnson
Daratumumab
Multiple Myeloma (MM)
BLA
85% (3% Above Avg.)
03/14/16
Takeda Pharmaceutical Company Ltd
Ixazomib
Multiple Myeloma (MM)
NDA
87% (5% Above Avg.)
03/18/16
Eagle Pharmaceuticals, Inc.
RTU bivalirudin
Percutaneous Coronary Interventions (PCIs) for Stable Angina
NDA
85% (Same As Avg.)
03/18/16
Elusys Therapeutics, Inc.
Anthim
Anthrax Infection (Antibacterial)
BLA
88% (Same As Avg.)
03/28/16
Takeda Pharmaceutical Company Ltd
Brintellix
Major Depressive Disorder (MDD)
Approved
100% (Same As Avg.)
03/29/16
Newron Pharmaceuticals SpA
Xadago
Parkinson’s Disease (PD)
NDA
86% (3% Above Avg.)
03/29/16
Opko Health
Rayaldee
Hyperparathyroidism (Secondary)
NDA
91% (2% Above Avg.)
03/30/16
Clovis Oncology, Inc.
Rociletinib
Non-Small Cell Lung Cancer (NSCLC)
NDA
98% (16% Above Avg.)
03/31/16
Gilead Sciences, Inc.
Zydelig
Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL
Approved
100% (Same As Avg.)
03/31/16
Jazz Pharmaceuticals plc
Defibrotide
Sinusoidal Obstruction Syndrome (Veno-Occlusive Disease / VOD)
NDA
84% (Same As Avg.)
04/01/16
INSYS Therapeutics, Inc.
Dronabinol Oral Solution
Chemotherapy Induced Nausea and Vomiting (CINV)
NDA
82% (Same As Avg.)
04/01/16
INSYS Therapeutics, Inc.
Dronabinol Oral Solution
HIV / AIDS Cachexia
NDA
89% (Same As Avg.)
04/07/16
Gilead Sciences, Inc.
Emtricitabine/tenofovir alafenamide
HIV / AIDS
NDA
93% (5% Above Avg.)
04/08/16
InSite Vision, Inc.
BromSite
Ocular Inflammation (Ophthalmology)
NDA
83% (4% Above Avg.)
04/15/16
Chiasma, Inc.
Octreolin
Acromegaly
NDA
89% (Same As Avg.)
04/19/16
Valeant Pharmaceuticals International, Inc.
Relistor (Oral)
Opioid Induced Constipation (OIC)
NDA
91% (2% Above Avg.)
04/29/16
Eisai Co., Ltd.
Fycompa
Partial Seizures (Epilepsy)
Approved
100% (Same As Avg.)
04/30/16
Flamel Technologies
Éclat Drug 4
Undisclosed
NDA
89% (Same As Avg.)
05/02/16
Allergan plc
Rosuvastatin Zinc
Dyslipidemia / Hypercholesterolemia
Approved
100% (Same As Avg.)
05/03/16
Acadia Pharmaceuticals, Inc.
Nuplazid
Parkinson’s Disease (PD)
NDA
89% (6% Above Avg.)
05/06/16
Evofem, Inc.
Amphora
Contraception
NDA
89% (Same As Avg.)
05/10/16
Biofrontera AG
Ameluz
Actinic Keratoses
NDA
91% (2% Above Avg.)
05/23/16
Johnson & Johnson
Olysio
Hepatitis C (HCV) (Antiviral)
Approved
100% (Same As Avg.)
05/26/16
ZS Pharma
ZS-9
Hyperkalemia
NDA
93% (4% Above Avg.)
05/27/16
Vanda Pharmaceuticals, Inc.
Fanapt
Schizophrenia
Approved
100% (Same As Avg.)
06/03/16
Allergan plc
Dalvance
Skin and Skin-Structure Infections (Antibacterial)
Approved
100% (Same As Avg.)
06/30/16
Lipocine Inc.
LPCN 1021
Hypogonadism
NDA
87% (2% Below Avg.)
07/11/16
Amgen, Inc.
Repatha
Dyslipidemia / Hypercholesterolemia
Approved
100% (Same As Avg.)
07/14/16
AbbVie Inc.
Imbruvica
Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL
Approved
100% (Same As Avg.)
07/15/16
Baxalta Incorporated
Gammagard (Subcutaneous)
Primary Immunodeficiencies
Approved
100% (Same As Avg.)
07/21/16
Valeant Pharmaceuticals International, Inc.
Vesneo
Glaucoma / Ocular Hypertension (Ophthalmology)
NDA
80% (1% Above Avg.)
07/25/16
Novo Nordisk A/S
Xultophy
Diabetes Mellitus, Type II
NDA
92% (3% Above Avg.)
07/28/16
Ocular Therapeutix, Inc.
Dextenza
Ocular Inflammation (Ophthalmology)
NDA
64% (15% Below Avg.)
07/29/16
ADMA Biologics, Inc.
RI-002
Primary Immunodeficiencies
BLA
87% (Same As Avg.)
08/25/16
Amgen, Inc.
Etelcalcetide
Hyperparathyroidism (Secondary)
NDA
93% (4% Above Avg.)
09/14/16
Dr. Reddy’s Laboratories
Xeglyze
Anti-parasitic and Anti-protozoal
NDA
93% (5% Above Avg.)
01/01/2016-03/31/2016
Allergan plc
Botox - Therapeutic
Neuromuscular Spasm and Spasticity
Approved
100% (Same As Avg.)
01/01/2016-03/31/2016
Eli Lilly & Company
Ixekizumab
Psoriasis
BLA
92% (5% Above Avg.)
01/01/2016-12/31/2016
Endologix, Inc.
Ventana
Aortic Aneurysm
IDE
N/A
01/23/2016-04/05/2016
Bristol-Myers Squibb Company
Daklinza
Hepatitis C (HCV) (Antiviral)
Approved
100% (Same As Avg.)
02/01/2016-02/29/2016
Merck & Co., Inc.
Vytorin
Dyslipidemia / Hypercholesterolemia
Approved
100% (Same As Avg.)
02/01/2016-02/29/2016
Merck & Co., Inc.
Zetia
Dyslipidemia / Hypercholesterolemia
Approved
100% (Same As Avg.)
02/01/2016-02/29/2016
Merz Pharmaceuticals GmbH
Xeomin
Neuromuscular Spasm and Spasticity
Approved
100% (Same As Avg.)
02/01/2016-02/29/2016
Pfizer Inc.
Xeljanz
Rheumatoid Arthritis (RA)
Approved
100% (Same As Avg.)
02/01/2016-04/18/2016
Novartis AG
Cosentyx
Psoriatic Arthritis (PA)
BLA
99% (12% Above Avg.)
02/01/2016-04/18/2016
Novartis AG
Cosentyx
Ankylosing Spondylitis
BLA
98% (11% Above Avg.)
02/11/2016-03/11/2016
Boehringer Ingelheim GmbH
Gilotrif
Non-Small Cell Lung Cancer (NSCLC)
Approved
100% (Same As Avg.)
02/18/2016-03/17/2016
Bristol-Myers Squibb Company
Elotuzumab
Multiple Myeloma (MM)
BLA
91% (9% Above Avg.)
02/19/2016-03/21/2016
AstraZeneca PLC
Osimertinib
Non-Small Cell Lung Cancer (NSCLC)
NDA
96% (14% Above Avg.)
03/01/2016-03/31/2016
Teva Pharmaceutical Industries Ltd.
Cinquil
Asthma
BLA
99% (2% Above Avg.)
03/01/2016-03/31/2016
Wellstat Therapeutics Corporation
Xuriden
Drug Toxicity
NDA
89% (Same As Avg.)
04/01/2016-04/30/2016
Teva Pharmaceutical Industries Ltd.
ProAir RespiClick
Asthma
Approved
100% (Same As Avg.)
04/01/2016-05/03/2016
Boehringer Ingelheim GmbH
Stiolto Respimat
Chronic Obstructive Pulmonary Disease (COPD)
Approved
100% (Same As Avg.)
04/01/2016-06/30/2016
Swedish Orphan Biovitrum
Orfadin
Tyrosinemia
Approved
100% (Same As Avg.)
04/01/2016-06/30/2016
Theravance Biopharma, Inc.
Vibativ
Skin and Skin-Structure Infections (Antibacterial)
Approved
100% (Same As Avg.)
04/01/2016-06/30/2016
Theravance Biopharma, Inc.
Vibativ
Hospital Acquired (Nosocomial) Pneumonia (HAP) (Antibacterial)
Approved
100% (Same As Avg.)
04/25/2016-05/25/2016
Otsuka Holdings Co., Ltd.
Abilify/Proteus
Schizophrenia
NDA
85% (Same As Avg.)
04/25/2016-05/25/2016
Otsuka Holdings Co., Ltd.
Abilify/Proteus
Bipolar Disorder
NDA
85% (Same As Avg.)
04/25/2016-05/25/2016
Otsuka Holdings Co., Ltd.
Abilify/Proteus
Major Depressive Disorder (MDD)
NDA
85% (Same As Avg.)
05/13/2016-06/10/2016
CSL Limited
CSL627
Hemophilia A
BLA
84% (Same As Avg.)
05/13/2016-06/14/2016
Osmotica Pharmaceutical Corp
Ontinua ER
Neuromuscular Spasm and Spasticity
NDA
83% (Same As Avg.)
05/19/2016-06/17/2016
Novartis AG
Biosimilar Etanercept (Sandoz)
Psoriasis
BLA
87% (Same As Avg.)
05/27/2016-06/28/2016
Teva Pharmaceutical Industries Ltd.
Austedo
Huntington’s Disease
NDA
90% (7% Above Avg.)
07/01/2016-08/07/2016
Luye Pharma Group, Ltd.
LY03004
Schizophrenia
NDA
85% (Same As Avg.)
07/01/2016-09/30/2016
Neos Therapeutics, Inc.
NT-0201
Attention Deficit Hyperactivity Disorder (ADHD)
I
7% (Same As Avg.)
07/15/2016-07/29/2016
Sanofi
Lyxumia
Diabetes Mellitus, Type II
NDA
97% (8% Above Avg.)
12/01/2015-01/31/2016
Biogen, Inc.
Zinbryta
Multiple Sclerosis (MS)
BLA
89% (6% Above Avg.)
12/01/2015-01/31/2016
Boehringer Ingelheim GmbH
Pradaxa
Venous Thromboembolism (VTE)
Approved
100% (Same As Avg.)
