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.
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 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: Amgen Inc.
Treatment for: High Cholesterol
Repatha (evolocumab) is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in development for the treatment of patients with high cholesterol.
- Amgen Publishes Safety Analysis Of Investigational Cholesterol-Lowering Medication Repatha (Evolocumab) - March 15, 2015
- New Detailed Data From Phase 3 Study Show Amgen's Repatha (Evolocumab) In Combination With Statins Reduced LDL-C By 67-76 Percent Compared To Placebo - March 14, 2015
- FDA Accepts Amgen's BLA For LDL Cholesterol-Lowering Medication Evolocumab - November 10, 2014
- Amgen Submits BLA For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab - August 28, 2014
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.
- 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: Merck & Co., Inc.
Treatment for: Reversal of Nondepolarizing Muscle Relaxants
Sugammadex is a novel selective relaxant binding agent (SRBA) in development for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
- Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection - March 13, 2015
- Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection - September 23, 2013
- Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection - July 16, 2013
- Merck Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection - January 7, 2013
- U.S. FDA Issues Action Letter for Sugammadex - August 1, 2008
- FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent - March 12, 2008
- Schering-Plough Announces New Drug Application for Sugammadex Assigned Priority Review Status by U.S. FDA - January 3, 2008
Company: Bristol-Myers Squibb Company
Treatment for: Chronic Hepatitis C
Daclatasvir is an NS5A replication complex inhibitor in development for the treatment of Hepatitis C.
ATX-101 (deoxycholic acid)
Company: Kythera Biopharmaceuticals, Inc.
Treatment for: Submental Fullness
ATX-101 (deoxycholic acid) is a formulation of a derived version of deoxycholic acid (a naturally occurring molecule in the body that aids in the breakdown of dietary fat) in development for the treatment of submental fullness, or double chin.
Zalviso (sufentanil) Sublingual Microtablet System
Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain
Zalviso (sufentanil sublingual microtablet system) is a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
- AcelRx Provides Regulatory Update on Zalviso - March 9, 2015
- AcelRx Pharmaceuticals Receives Complete Response Letter from FDA for NDA for Zalviso - July 25, 2014
- Zalviso New Drug Application Accepted for Filing by FDA - December 2, 2013
- AcelRx Pharmaceuticals Submits New Drug Application to the FDA for Zalviso - September 30, 2013
Kovaltry (factor VIII (recombinant))
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Hemophilia A
Kovaltry (factor VIII (recombinant)) is an investigational plasma protein-free compound in development for the treatment of hemophilia A.
Company: Actelion Ltd.
Treatment for: Pulmonary Hypertension
Uptravi (selexipag) is a potent, orally available, selective IP prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension.
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Reversal Agent for Pradaxa
Idarucizumab is a humanized antibody fragment, or Fab, being investigated as a specific reversal agent for the anticoagulant effect of dabigatran (Pradaxa).
Company: Shire plc
Treatment for: Dry Eye Disease
Lifitegrast is a topical integrin antagonist in development for the treatment of dry eye disease.
Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease
Xadago (safinamide) is an alpha-aminoamide in development as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease.
- Xadago (safinamide) NDA Accepted for Filing by the U.S. FDA - March 2, 2015
- Safinamide NDA Re-submitted to the U.S. FDA - December 29, 2014
Company: Mapp Biopharmaceutical, Inc.
Treatment for: Ebola Virus Disease
ZMapp is a combination of three chimeric monoclonal antibodies manufactured in the Nicotiana benthamiana tobacco plant that has been used in the experimental treatment of Ebola virus disease.
Company: Otonomy, Inc.
Treatment for: Otitis Media
AuriPro (ciprofloxacin) is a sustained-exposure otic fluoroquinolone formulation in development for the treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery.
- Otonomy Submits New Drug Application to the FDA for AuriPro - February 26, 2015
Belbuca (buprenorphine hydrochloride) Buccal Film
Company: Endo Pharmaceuticals Inc.
Treatment for: Chronic Pain
Belbuca (buprenorphine) is an opioid analgesic buccal film formulation in development for the management of chronic pain.
TAS-102 (tipiracil hydrochloride and trifluridine)
Company: Taiho Oncology, Inc.
Treatment for: Colorectal Cancer
TAS-102 (trifluridine and tipiracil hydrochloride) is an antineoplastic nucleoside analog and thymidine phosphorylase inhibitor combination in development for the treatment of refractory metastatic colorectal cancer (mCRC).
Treatment for: Melanoma - Metastatic
Cobimetinib is an investigational MEK inhibitor in development for the combination treatment of advanced melanoma.
Company: Oncolytics Biotech Inc.
Treatment for: Ovarian Cancer, Pancreatic Cancer
Reolysin (pelareorep) is a proprietary formulation of the human reovirus (Respiratory Enteric Orphan Virus) in development for the treatment of various cancers and cell proliferative disorders.
Company: Sprout Pharmaceuticals, Inc.
Treatment for: Hypoactive Sexual Desire Disorder
Flibanserin is a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) in development for the treatment of hypoactive sexual desire disorder in premenopausal women.
- 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