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.
Cresemba (isavuconazonium) is a novel, water-soluble prodrug of the triazole isavuconazole, in development for the treatment of invasive aspergillosis and mucormycosis.
Company: UCB, Inc.
Treatment for: Epilepsy
Brivaracetam is an analogue of levetiracetam in development for the treatment of partial-onset seizures in patients with epilepsy.
Company: Forest Laboratories, Inc. and 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 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
Company: Marathon Pharmaceuticals, LLC
Treatment for: Duchenne Muscular Dystrophy
Deflazacort is a glucocorticoid in development for the treatment of Duchenne Muscular Dystrophy.
Company: Pfizer Inc.
Treatment for: Breast Cancer
Ibrance (palbociclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in development for the combination treatment of ER+, HER2- metastatic breast cancer.
- Pfizer Provides Update on Ibrance (palbociclib) - January 8, 2015
- Pfizer Announces Palbociclib PALOMA-1 Data Published in The Lancet Oncology - December 15, 2014
- 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
Treatment for: Neutropenia Associated with Chemotherapy
Zarxio (filgrastim) is an investigational biosimilar (reference product Amgen’s Neupogen®) under review for the treatment of neutropenia associated with chemotherapy.
patiromer for Oral Suspension
Company: Relypsa, Inc.
Treatment for: Hyperkalemia
Patiromer is an oral potassium binder in development for the treatment of hyperkalemia.
- Relypsa Announces October 21, 2015 as PDUFA Date for NDA for Patiromer for Oral Suspension - January 5, 2015
- Relypsa Announces FDA Acceptance of New Drug Application for Patiromer for Oral Suspension to Treat Hyperkalemia - December 15, 2014
- Relypsa Submits NDA for Patiromer for Oral Suspension to Treat Hyperkalemia - October 22, 2014
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Hypophosphatasia
Asfotase alfa is an investigational, first-in-class enzyme replacement therapy for the treatment of hypophosphatasia.
Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease
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.
- Safinamide NDA Re-submitted to the U.S. FDA - December 29, 2014
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: Forest Laboratories, Inc.
Treatment for: Hypertension
Nebivolol/Valsartan is an investigational fixed dose combination in development for the treatment of hypertension.
Company: PTC Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy
Translarna (ataluren) is a protein restoration therapy in development for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).
Company: Actelion Ltd.
Uptravi (selexipag) is a potent, orally available, selective IP prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension.
Yosprala (aspirin and omeprazole)
Company: Pozen Inc.
Treatment for: Ischemic Stroke -- Prophylaxis, Gastric Ulcer Prophylaxis
Yosprala (aspirin and omeprazole) is a platelet aggregation inhibitor and proton pump inhibitor combination in development for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers.
- Pozen’s Yosprala Receives Complete Response Letter from the FDA - December 17, 2014
Xtampza ER (oxycodone) Extended-Release Capsules
Company: Collegium Pharmaceutical, Inc.
Treatment for: Chronic Pain
Xtampza ER (oxycodone) is an extended-release, abuse-deterrent narcotic analgesic in development for the treatment of chronic pain.
Treatment for: Melanoma - Metastatic
Cobimetinib is an investigational MEK inhibitor in development for the combination treatment of advanced melanoma.
Company: Jazz Pharmaceuticals plc
Treatment for: Hepatic Veno-Occlusive Disease
Defibrotide is a deoxyribonucleic acid derivative anticoagulant in development for the treatment of severe hepatic veno-occlusive disease (VOD).