New Drug Applications
The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions
- Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks
- Whether the drug's proposed labeling (package insert) is appropriate and what it should contain
- Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity
For more information on New Drug Applications, please visit the FDA's How Drugs are Developed and Approved page.
Company: Clovis Oncology, Inc.
Treatment for: Non-Small Cell Lung Cancer
Rociletinib is a mutant-selective inhibitor of epidermal growth factor receptor (EGFR) in development for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC).
ZS-9 (sodium zirconium cyclosilicate)
Company: ZS Pharma, Inc.
Treatment for: Hyperkalemia
ZS-9 (sodium zirconium cyclosilicate) is a crystalline lattice potassium ion-trap in development for the treatment of hyperkalemia.
Company: Merck & Co., Inc.
Treatment for: Chronic Hepatitis C
Elbasvir and grazoprevir is an investigational, once-daily single tablet NS5A replication complex inhibitor and NS3/4A protease inhibitor combination in development for the treatment of multiple HCV genotypes.
Company: OPKO Health, Inc.
Treatment for: Secondary Hyperparathyroidism
Rayaldee (calcifediol modified-release) is a first-in-class oral vitamin D prohormone treatment in development for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.
- FDA Accepts OPKO's New Drug Application for Rayaldee - July 28, 2015
- OPKO Announces Submission of Rayaldee NDA - June 2, 2015
Company: Takeda Pharmaceutical Company Limited
Treatment for: Multiple Myeloma
Ixazomib is an investigational oral proteasome inhibitor in development for the treatment of patients with relapsed and/or refractory multiple myeloma.
Company: Ignyta, Inc.
Treatment for: Neuroblastoma
Entrectinib is a potent, novel, orally available, selective tyrosine kinase inhibitor in development for the treatment of neuroblastoma.
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Emtricitabine/rilpivirine/tenofovir alafenamide is an investigational nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination in development for the treatment of HIV-1 infection.
Treatment for: Melanoma - Metastatic
Cobimetinib is an investigational MEK inhibitor in development for the combination treatment of advanced melanoma.
- Exelixis Provides Update on Genentech’s Pending NDA for Cobimetinib - July 1, 2015
- FDA Grants Genentech's Cobimetinib Priority Review for Use in Combination with Zelboraf in Advanced Melanoma - February 18, 2015
- Genentech Submits NDA to FDA for Investigational Cobimetinib Used in Combination with Zelboraf (vemurafenib) in Advanced Melanoma - December 14, 2014
Company: Intercept Pharmaceuticals, Inc.
Treatment for: Biliary Cirrhosis
Obeticholic acid is a first-in-class farnesoid X receptor (FXR) agonist in development for the treatment of primary biliary cirrhosis.
Treatment for: Duchenne Muscular Dystrophy
Eteplirsen is a morpholino antisense oligomer in development for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.
- Sarepta Therapeutics Completes NDA Submission to FDA for Eteplirsen - June 29, 2015
- Sarepta Therapeutics Announces Regulatory Update on Eteplirsen - October 27, 2014
- Sarepta Therapeutics Announces Plans to Submit NDA to FDA for Eteplirsen for Duchenne Muscular Dystrophy - April 21, 2014
- Sarepta Therapeutics Announces FDA Considers NDA Filing for Eteplirsen Premature in Light of Recent Competitive Drug Failure and Recent DMD Natural History Data - November 12, 2013
- Sarepta Therapeutics Announces Plans to Submit New Drug Application to FDA for Eteplirsen for the Treatment of Duchenne Muscular Dystrophy in First Half of 2014 - July 25, 2013
MM-398 (irinotecan liposomal) Injection
Company: Merrimack Pharmaceuticals, Inc.
Treatment for: Pancreatic Cancer
MM-398 (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan in development for the treatment of post-gemcitabine metastatic adenocarcinoma of the pancreas.
Company: Gedeon Richter plc
Treatment for: Schizophrenia, Bipolar Disorder
Cariprazine is a potent dopamine D3/D2 receptor partial agonist in development for the treatment of schizophrenia and bipolar I disorder.
- Richter And Allergan Announce FDA Has Extended The Review Period For Cariprazine To September 2015 - June 16, 2015
- Richter and Actavis Announce Positive Phase III Results for Cariprazine in the Prevention of Relapse in Patients with Schizophrenia - January 20, 2015
- Actavis and Gedeon Richter Announce FDA Receipt of NDA Resubmission for Cariprazine - January 6, 2015
- Forest Laboratories and Gedeon Richter Receive Complete Response Letter for Cariprazine - November 21, 2013
- Forest Laboratories Submits New Drug Application for Cariprazine for the Treatment of Both Schizophrenia and Manic or Mixed Episodes Associated with Bipolar I Disorder - November 28, 2012
BromSite (bromfenac) Ophthalmic Solution
Company: InSite Vision Incorporated
Treatment for: Postoperative Ocular Inflammation
BromSite (bromfenac) is a low dose nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution in development for the treatment of inflammation and prevention of pain in cataract surgery.
Company: GlaxoSmithKline plc
Treatment for: Asthma
Mepolizumab is an anti-IL5 monoclonal antibody in development for the treatment of patients with severe eosinophilic asthma.
Company: Santhera Pharmaceuticals
Treatment for: Duchenne Muscular Dystrophy
Idebenone is a synthetic short-chain benzoquinone and a substrate for the enzyme NAD(P)H:quinone oxidoreductase (NQO1) in development for the treatment of Duchenne Muscular Dystrophy.
Praluent (alirocumab) Injection
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: High Cholesterol
Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody for the treatment of heterozygous familial hypercholesterolemia, or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.
- FDA Approves Praluent (alirocumab) to Treat Certain Patients with High Cholesterol - July 24, 2015
- FDA Advisory Committee Recommends Approval of Praluent (Alirocumab) Injection for Patients with Hypercholesterolemia - June 9, 2015
- Sanofi and Regeneron Announce 18-Month Results of ODYSSEY LONG TERM Trial With Praluent (Alirocumab) - March 15, 2015
- Sanofi and Regeneron Announce Praluent (alirocumab) BLA Accepted for Priority Review by FDA - January 26, 2015
- Sanofi and Regeneron Announce Positive Topline Results from Phase 3 Trials Evaluating Monthly Alirocumab - January 9, 2015
Company: Repros Therapeutics Inc.
Treatment for: Hypogonadism -- Male
Androxal (enclomiphene) is a non-steroidal estrogen receptor antagonist in development for secondary hypogonadism in overweight men wishing to restore normal testicular function.
- Repros Announces Date of FDA Advisory Committee Review of NDA - June 8, 2015
- Repros Announces November 30, 2015 PDUFA Goal Date for Enclomiphene Citrate NDA - April 15, 2015
- Repros Submits New Drug Application to FDA for Androxal - February 2, 2015
- Repros Reports Both Primary Endpoints Successfully Met in First Pivotal Study of Androxal - March 27, 2013
- Repros Submits Response to FDA Regarding Androxal Indication for Treatment of Hypogonadal Men Wishing to Preserve Fertility - February 8, 2010
Treatment for: Diabetes Type 2
Lyxumia (lixisenatide) is a once-daily prandial GLP-1 receptor agonist in development for the treatment of adults with type 2 diabetes mellitus.
- Sanofi's Lyxumia (lixisenatide) Demonstrated Cardiovascular Safety in People With Type 2 Diabetes and High CV Risk - June 8, 2015
- Lyxumia (Lixisenatide) Meets Co-Primary Endpoints in GetGoal Duo-2 Trial - June 6, 2015
- Sanofi Announces Top-Line Results for Cardiovascular Outcomes Study of Lyxumia (Lixisenatide) - March 19, 2015
- Sanofi's Lyxumia (lixisenatide) Showed More Pronounced After-Test-Meal Blood Sugar Lowering than Liraglutide when Both were Added to Insulin Glargine - June 14, 2014
- Sanofi Provides Update on Lixisenatide New Drug Application in U.S. - September 12, 2013
- Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA - February 19, 2013
Company: Titan Pharmaceuticals, Inc.
Treatment for: Opiate Dependence
Probuphine (buprenorphine) is an opioid partial agonist subdermal implant in development for the treatment of opioid dependence.
- Titan Pharmaceuticals Reports Positive Results from Phase 3 Study of Probuphine for Opioid Addiction - June 8, 2015
- Titan Pharmaceuticals Receives Complete Response Letter From the FDA for Probuphine New Drug Application - May 1, 2013
- Titan Pharmaceuticals Announces Date of FDA Advisory Committee Review of Probuphine for the Treatment of Opioid Dependence - February 27, 2013
- Titan Pharmaceuticals Announces Submission of New Drug Application for Probuphine for the Treatment of Opioid Dependence - October 29, 2012