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.
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.
Orkambi (ivacaftor and lumacaftor)
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis
Orkambi (ivacaftor and lumacaftor) is a CFTR potentiator and CFTR corrector combination designed to treat the underlying cause of cystic fibrosis in people with two copies of the F508del mutation.
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 Pharmaceuticals Provides Zalviso Regulatory Update - May 4, 2015
- 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
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 Announces FDA Advisory Committee Meeting to Review Repatha (Evolocumab) for High Cholesterol - April 29, 2015
- 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
Zinbryta (daclizumab high-yield process)
Company: AbbVie, Inc. and Biogen
Treatment for: Multiple Sclerosis
Zinbryta (daclizumab high-yield process) is an investigational humanized monoclonal antibody in development for the treatment of relapsing forms of multiple sclerosis (MS).
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 Announces FDA Acceptance of AuriPro New Drug Application - April 28, 2015
- Otonomy Submits New Drug Application to the FDA for AuriPro - February 26, 2015
Company: Prosensa Holding N.V.
Treatment for: Duchenne Muscular Dystrophy
Drisapersen is an investigational antisense oligonucleotide in development for the treatment of Duchenne Muscular Dystrophy.
- BioMarin Completes Rolling NDA Submission to FDA for Drisapersen for Duchenne Muscular Dystrophy - April 27, 2015
- Prosensa Begins NDA Submission for Drisapersen to treat Duchenne Muscular Dystrophy - October 10, 2014
- Prosensa Announces Regulatory Path Forward for Drisapersen as a Potential Treatment for DMD - June 3, 2014
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: Ultragenyx Pharmaceutical Inc.
Treatment for: Glucose Transporter Type-1 Deficiency Syndrome
Triheptanoin is a synthetic triglyceride compound in development for the treatment of glucose transporter type-1 deficiency syndrome (Glut1 DS).
Company: Oncolytics Biotech Inc.
Treatment for: Ovarian Cancer, Pancreatic Cancer, Malignant Glioma
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.
- Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from the FDA for Malignant Gliomas - April 17, 2015
- Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from FDA for Reolysin for Pancreatic Cancer - February 17, 2015
- Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from FDA for Reolysin for Ovarian Cancer - February 11, 2015
Company: The Medicines Company
Treatment for: Platelet Aggregation Inhibition
Cangrelor is an intravenous antiplatelet drug in development for use in patients undergoing percutaneous coronary intervention (PCI) and those that require bridging from oral antiplatelet therapy to surgery.
- FDA Advisory Committee Recommends Approval of The Medicines Company's Antiplatelet Therapy Cangrelor - April 15, 2015
- The Medicines Company Receives Complete Response Letter From FDA for Antiplatelet Agent Cangrelor - April 30, 2014
- FDA Advisory Committee Recommends Against Antiplatelet Therapy Cangrelor - February 12, 2014
- Totality of Data From Three Phase III Trials of The Medicines Company's Intravenous Cangrelor Presented and Published - September 3, 2013
- FDA Accepts the Filing of The Medicines Company's New Drug Application for Intravenous Antiplatelet Agent Cangrelor - July 1, 2013
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 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
Company: ARCA biopharma, Inc.
Treatment for: Congestive Heart Failure
Gencaro (bucindolol) is an investigational and pharmacologically unique beta-blocker and mild vasodilator in development for the treatment of chronic heart failure.
- ARCA Biopharma Receives FDA Fast Track Designation for Gencaro - April 13, 2015
- ARCA biopharma Receives Complete Response Letter From FDA on the Gencaro NDA - June 1, 2009
- FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma - September 23, 2008
Macrilen (macimorelin acetate)
Company: Aeterna Zentaris Inc.
Treatment for: Adult Human Growth Hormone Deficiency
Macrilen (macimorelin) is a ghrelin agonist in development for use in evaluating adult growth hormone deficiency (AGHD).
- Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of Macrilen in AGHD - April 13, 2015
- FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency - November 6, 2014
- Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA - January 6, 2014
- Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD - November 5, 2013
Company: Shire plc
Treatment for: Dry Eye Disease
Lifitegrast is a topical integrin antagonist in development for the treatment of dry eye disease.
- U.S. FDA Grants Priority Review to Lifitegrast NDA for the Treatment of Dry Eye Disease in Adults - April 9, 2015
- Shire Submits NDA to the FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults - March 2, 2015
- Shire Plans to Submit a New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults - May 16, 2014
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Emtricitabine/tenofovir alafenamide is an investigational nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination in development for the treatment of HIV-1 infection.
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: 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