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: Bristol-Myers Squibb Company
Treatment for: Melanoma - Metastatic
Opdivo (nivolumab) is an investigational PD-1 immune checkpoint inhibitor in development for the treatment of advanced melanoma.
- Study Comparing Opdivo (nivolumab) to Chemotherapy Demonstrates Survival Benefit - November 16, 2014
- Phase 2 Objective Response Rate and Survival Data for Opdivo (nivolumab) in NSCLC to be Presented - October 30, 2014
- BMS Announces Collaboration to Evaluate Opdivo (nivolumab) in Combination to Treat Non-Small Cell Lung Cancer - October 6, 2014
- Bristol-Myers Squibb Announces Multiple Regulatory Milestones for Opdivo (nivolumab) - September 26, 2014
Company: Chimerix, Inc.
Treatment for: Ebola Virus Disease
Brincidofovir is a nucleotide analog broad-spectrum antiviral under FDA review to assess the safety and efficacy in patients with confirmed Ebola virus infection.
Company: Amgen Inc.
Treatment for: Hyperlipidemia
Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) in development for the treatment for dyslipidemia.
Company: Novartis Pharmaceuticals Corporation
Treatment for: Plaque Psoriasis
Secukinumab is a selective interleukin-17A (IL-17A) inhibitor in development for the treatment of moderate-to-severe plaque psoriasis.
Company: Avanir Pharmaceuticals, Inc.
Treatment for: Migraine
AVP-825 (sumatriptan) is an investigational fast-acting, dry-powder intranasal form of sumatriptan in development for the treatment of migraine.
- Avanir Pharmaceuticals Announces Preliminary Feedback from the FDA on AVP-825 for the Acute Treatment of Migraine - November 7, 2014
- Avanir Pharmaceuticals Announces Publication of Pivotal Phase III Results from AVP-825 Acute Migraine Study - October 30, 2014
- Avanir Pharmaceuticals Announces Acceptance of NDA for AVP-825 for the Acute Treatment of Migraine - March 26, 2014
- Avanir Pharmaceuticals Announces Submission of New Drug Application for AVP-825 for the Acute Treatment of Migraine - January 30, 2014
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).
- 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
Treatment for: Multiple Myeloma
LBH589 (panobinostat) is a pan-deacetylase (pan-DAC) inhibitor in development for the combination treatment of multiple myeloma.
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis
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.
Company: GlaxoSmithKline plc
Treatment for: Asthma
Mepolizumab is an anti-IL5 monoclonal antibody in development for the treatment of patients with severe eosinophilic asthma.
Treatment for: Aspergillosis -- Invasive
Isavuconazole is a broad-spectrum antifungal in development for the treatment of invasive aspergillosis and invasive mucormycosis.
Company: Daiichi Sankyo Company
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism
Savaysa (edoxaban) is an investigational, oral, once-daily factor Xa inhibitor anticoagulant in development for the reduction in risk of stroke in patients with non-valvular atrial fibrillation (NVAF), and deep vein thrombosis (DVT) or pulmonary embolism.
Treatment for: Duchenne Muscular Dystrophy
Eteplirsen is a morpholino antisense oligomer in development for the treatment of Duchenne muscular dystrophy (DMD).
- 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
Company: Pain Therapeutics, Inc. and King Pharmaceuticals, Inc.
Treatment for: Pain
Remoxy (oxycodone) is a long-acting abuse-resistant narcotic analgesic formulation in development for the treatment of moderate to severe chronic pain.
- Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII - October 27, 2014
- FDA Complete Response Letter Received for Remoxy - June 24, 2011
- Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011 - January 27, 2011
- King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for Remoxy - December 27, 2010
- Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy - December 11, 2008
- Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy - June 10, 2008
patiromer for Oral Suspension
Company: Relypsa, Inc.
Treatment for: Hyperkalemia
Patiromer is an oral potassium binder being developed for the treatment of hyperkalemia.
- Relypsa Submits NDA for Patiromer for Oral Suspension to Treat Hyperkalemia - October 22, 2014
Company: Eli Lilly and Company and Boehringer Ingelheim
Treatment for: Diabetes Type 2
Empagliflozin and Metformin is a sodium glucose co-transporter-2 (SGLT2) inhibitor and biguanide combination in development for the treatment of type 2 diabetes.
Company: Eisai Co., Ltd.
Treatment for: Thyroid Cancer
Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor in development for the treatment of progressive radioiodine-refractory differentiated thyroid cancer.
Company: Pfizer Inc.
Treatment for: Breast Cancer
Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in development for the combination treatment of ER+, HER2- metastatic breast cancer.
- Pfizer Announces FDA Acceptance Of Palbociclib New Drug Application With Priority Review - October 13, 2014
- Palbociclib Expanded Access Program Now Open To Eligible U.S. Patients With HR+, HER2- Advanced Breast Cancer - August 21, 2014
- Pfizer Announces Submission of Palbociclib New Drug Application to the FDA - August 18, 2014
- Pfizer To Submit Palbociclib New Drug Application With FDA Based On Final Results Of PALOMA-1 - May 16, 2014