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.
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
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 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
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.
patiromer for Oral Suspension
Company: Relypsa, Inc.
Treatment for: Hyperkalemia
Patiromer is an oral potassium binder in development for the treatment of hyperkalemia.
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).
Company: Hemispherx Biopharma, Inc.
Treatment for: Chronic Fatigue Syndrome
Ampligen is an experimental nucleic acid therapeutic being developed for the potential treatment of Chronic Fatigue Syndrome (CFS).
- Hemispherx Announces Data Showing Inhibition of Ebola by Ampligen Enlarged by Howard University Research - December 9, 2014
- Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen New Drug Application for Chronic Fatigue Syndrome - February 5, 2013
- FDA Advisory Committee Makes Recommendations on Ampligen for Chronic Fatigue Syndrome - December 27, 2012
- Hemispherx Biopharma Announces FDA Confirms Advisory Committee Meeting on December 20, 2012 - October 23, 2012
- Hemispherx Biopharma Announces FDA Advisory Committee Will Review Ampligen for Chronic Fatigue Syndrome - September 24, 2012
- FDA Accepts Complete Response Submission Regarding the Ampligen New Drug Application for Chronic Fatigue Syndrome - August 14, 2012
- Hemispherx Biopharma Files Complete Response With the FDA Regarding Its Ampligen New Drug Application for Chronic Fatigue Syndrome - August 1, 2012
- Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps to Achieve Complete NDA on Proposed CFS Treatment Ampligen - March 7, 2008
- Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA - January 9, 2008
- Hemispherx Biopharma Files New Drug Application for Ampligen as Treatment for Chronic Fatigue Syndrome - October 11, 2007
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.
- Opdivo (nivolumab) Demonstrates High Overall Response Rate of 87% for Treatment of Relapsed or Refractory Hodgkin Lymphoma - December 6, 2014
- 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: Actavis plc
Treatment for: Intraabdominal Infection
Avibactam and ceftazidime is a next generation, non-β lactam β-lactamase inhibitor and third-generation, antipseudomonal cephalosporin investigational antibiotic combination in development for the treatment of complicated intra-abdominal infections.
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 Receives Complete Response Letter (CRL) from FDA on AVP-825 NDA - November 26, 2014
- 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
Company: Ortho Biotech Products, L.P.
Treatment for: Ovarian Cancer
Yondelis (trabectedin) is an investigational cytotoxic antitumor agent in development for the treatment of relapsed ovarian cancer, and advanced soft tissue sarcoma.
- Janssen Submits NDA for Yondelis (trabectedin) for Advanced Soft Tissue Sarcoma - November 24, 2014
- Centocor Ortho Biotech Products, L.P. Voluntarily Withdraws NDA for Trabectedin - April 29, 2011
- FDA Issues Complete Response Letter For Trabectedin Combined With Doxil - September 10, 2009
- Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer - November 20, 2008
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.
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.