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: 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.
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: High Cholesterol
Praluent (alirocumab) an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in development for the treatment of patients with high cholesterol.
- 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
Company: Janssen Research & Development, LLC
Treatment for: Multiple Myeloma
Daratumumab is an investigational human anti-CD38 monoclonal antibody in development for the treatment of patients with multiple myeloma.
- Janssen Initiates Rolling Submission of BLA for Daratumumab for the Treatment of Multiple Myeloma - June 5, 2015
- Genmab Announces Preliminary Results in Phase II Study of Daratumumab in Double Refractory Multiple Myeloma - February 3, 2015
- Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab - August 30, 2012
Addyi (flibanserin) tablet
Company: Sprout Pharmaceuticals, Inc.
Treatment for: Hypoactive Sexual Desire Disorder
Addyi (flibanserin) is a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) in development for the treatment of hypoactive sexual desire disorder in premenopausal women.
- FDA Advisory Committee Recommends Approval for Addyi (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women - June 4, 2015
- Sprout Pharmaceuticals Resubmits Flibanserin NDA for Hypoactive Sexual Desire Disorder In Premenopausal Women - February 17, 2015
- Sprout Pharmaceuticals Receives Clear Guidance from FDA on Path Forward to Resubmit NDA for Flibanserin - February 11, 2014
- Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women - December 11, 2013
- Following Regulatory Feedback Boehringer Ingelheim Decides to Discontinue Flibanserin Development - October 8, 2010
- Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder - May 19, 2010
Locilex (pexiganan) Cream
Company: Dipexium Pharmaceuticals, Inc.
Treatment for: Diabetic Foot Infection
Locilex (pexiganan cream 0.8%) is a topical antibiotic in development for the treatment of patients with diabetic foot infection.
Company: OPKO Health, Inc.
Treatment for: Secondary Hyperparathyroidism
Rayaldee (calcifediol) 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.
- OPKO Announces Submission of Rayaldee NDA - June 2, 2015
Company: Elusys Therapeutics, Inc.
Treatment for: Anthrax Prophylaxis, Inhalation Bacillus anthracis
Anthim (obiltoxaximab) is a high-affinity monoclonal antibody in development for the treatment and prevention of inhalational anthrax.
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.
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.
Dyanavel XR (amphetamine)
Company: Tris Pharma, Inc.
Treatment for: ADHD
Dyanavel XR (amphetamine) is an extended-release oral suspension formulation of amphetamine in development for the treatment of children with ADHD.