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: Boehringer Ingelheim and Eli Lilly and Company
Treatment for: Diabetes Type 2
Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor in development for the treatment of type 2 diabetes.
Company: Forest Laboratories, Inc. and Adamas Pharmaceuticals Inc.
Treatment for: Alzheimer's Disease
Memantine ER/Donepezil is a fixed-dose combination (FDC) in development for the treatment of moderate to severe dementia of the Alzheimer’s type.
Company: XOMA Corporation
Treatment for: Uveitis
Gevokizumab is a potent monoclonal antibody in development for the treatment of non-infectious uveitis.
Company: Forest Laboratories, Inc.
Nebivolol/Valsartan is an investigational fixed dose combination in development for the treatment of hypertension.
Company: InterMune, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis
Esbriet (pirfenidone) is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone is in development for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
- InterMune Reports Phase 3 ASCEND Trial Results of Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF) - February 25, 2014
- Coalition for Pulmonary Fibrosis Responds to News of Further Review of Pirfenidone By FDA - May 7, 2010
- InterMune Receives FDA Complete Response Letter on Esbriet (pirfenidone) New Drug Application - May 5, 2010
- FDA Advisory Committee Recommends Approval of InterMune's Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis - March 10, 2010
- InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone - March 5, 2010
- FDA Grants Priority Review of Pirfenidone NDA for the Treatment of Patients With IPF - January 6, 2010
- InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF - November 4, 2009
Company: BioCryst Pharmaceuticals, Inc.
Treatment for: Influenza
Peramivir is an intravenously administered anti-viral agent in development for the treatment of influenza, including H7N9 and pandemic H1N1 swine flu viral strains.
- BioCryst Announces Peramivir NDA Acceptance by the FDA - February 25, 2014
Company: Targanta Therapeutics Corporation
Treatment for: Skin and Structure Infection
Oritavancin is a semi-synthetic lipoglycopeptide antibiotic being developed for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
- FDA Accepts Filing of NDA for IV Antibiotic Oritavancin with Priority Review - February 20, 2014
- FDA Issues Complete Response Letter for Oritavancin - December 9, 2008
- Targanta Announces Review of Oritavancin at FDA Anti-Infective Drugs Advisory Committee Meeting - October 15, 2008
- Targanta Announces FDA Acceptance of Oritavancin New Drug Application - April 9, 2008
- Targanta Submits Oritavancin New Drug Application - February 11, 2008
Company: AVEO Oncology and Astellas Pharma Inc.
Treatment for: Renal Cell Carcinoma
Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor in development for the treatment of advanced renal cell carcinoma.
- AVEO and Astellas to End Worldwide Collaboration & License Agreement for Tivozanib - February 15, 2014
- AVEO Provides Update on Interim Analysis from Tivozanib Trial in Colorectal Cancer - December 16, 2013
- AVEO Announces Complete Response Letter Received for Tivozanib New Drug Application in Renal Cell Carcinoma - June 10, 2013
- AVEO and Astellas Report FDA Oncologic Drug Advisory Committee Votes Tivozanib Application Did Not Demonstrate Favorable Benefit-to-Risk Evaluation in Treatment of Advanced Renal Cell Carcinoma - May 2, 2013
- AVEO and Astellas Announce FDA Advisory Committee To Review Tivozanib for the Treatment of Advanced Renal Cell Carcinoma - February 27, 2013
- AVEO and Astellas Announce FDA Acceptance of NDA Filing for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma - November 28, 2012
- AVEO and Astellas Announce Submission of New Drug Application for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma - September 28, 2012
Northera (droxidopa) Capsules
Company: Chelsea Therapeutics International, Ltd.
Treatment for: Neurogenic Orthostatic Hypotension
Northera (droxidopa) is an orally active synthetic precursor of norepinephrine indicated for the treatment of neurogenic orthostatic hypotension.
- FDA Approves Northera to treat Neurogenic Orthostatic Hypotension - February 18, 2014
- Chelsea Therapeutics Issues Statement Regarding Postponement of Northera NDA PDUFA Date - February 14, 2014
- FDA Advisory Panel Recommends Approval of Chelsea Therapeutics' Northera (Droxidopa) for the Treatment of Symptomatic nOH - January 14, 2014
- Chelsea Therapeutics Announces FDA Advisory Committee to Review Northera - October 9, 2013
- Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission - September 4, 2013
- Chelsea Therapeutics Announces Submission of Additional Information for Northera NDA - August 15, 2013
- Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission - July 17, 2013
- Chelsea Therapeutics Resubmits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH - July 9, 2013
- Chelsea Therapeutics Receives FDA Guidance for a Northera (Droxidopa) NDA Resubmission With Study 306B - February 20, 2013
- Chelsea Therapeutics Provides an Update on Northera (droxidopa) Regulatory Status and Development Program - July 3, 2012
- Chelsea Therapeutics Completes End-of-Review Meeting With FDA for Northera (droxidopa) NDA - May 22, 2012
- Chelsea Therapeutics Receives Complete Response Letter from Food and Drug Administration for Northera (droxidopa) Capsules - March 28, 2012
- FDA Advisory Panel Recommends Approval of Chelsea's Northera (droxidopa) for the Treatment of Symptomatic Neurogenic OH - February 24, 2012
- Chelsea Therapeutics CEO to Review Northera NDA and Provide an Update on Upcoming Advisory Committee Meeting During Presentation at BIO CEO - February 14, 2012
- Chelsea Therapeutics Announces FDA Advisory Committee Meeting Date for Review of Northera NDA for the Treatment of Symptomatic NOH - January 5, 2012
- Chelsea Therapeutics Submits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH - September 28, 2011
- Chelsea Therapeutics Accelerates Northera NDA Filing Following Meeting With FDA - December 20, 2010
- Chelsea Therapeutics Announces Advancements in Neurogenic Orthostatic Hypotension Registration Program - February 9, 2010
Company: NicOx S.A.
Treatment for: Osteoarthritis
Naproxcinod is the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators) in development for the relief of the signs and symptoms of osteoarthritis.
- Nicox to re-focus Naproxcinod on Duchenne Muscular Dystrophy - February 14, 2014
- NicOx Provides Update on U.S. Regulatory Status of Naproxcinod - April 4, 2012
- FDA provides Complete Response Letter to NicOx's New Drug Application for naproxcinod - July 22, 2010
- NicOx provides update on FDA Advisory Committee Meeting for naproxcinod - May 13, 2010
- NicOx announces FDA Advisory Committee to discuss naproxcinod on May 12 - March 8, 2010
- NicOx announces FDA accepts naproxcinod NDA for filing - November 18, 2009
- NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA - September 25, 2009
Company: The Medicines Company
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 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: Sprout Pharmaceuticals, Inc.
Treatment for: Hypoactive Sexual Desire Disorder
Flibanserin is a novel, non-hormonal drug in development for the treatment of hypoactive sexual desire disorder in premenopausal women.
Company: Melinta Therapeutics
Treatment for: Gonococcal Infection -- Uncomplicated
Delafloxacin is a novel investigational fluoroquinolone in development for the treatment of uncomplicated gonorrhea.
Company: Gilead Sciences, Inc.
Treatment for: Chronic Hepatitis C
Ledipasvir/Sofosbuvir is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor fixed-dose combination in development for the treatment of chronic hepatitis C genotype 1 infection.
Company: Alcobra Ltd.
Treatment for: Attention Deficit Disorder
Metadoxine is an ion-pair salt of pyridoxine (vitamin B6) in development for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Peripheral T-cell Lymphoma
Beleodaq (belinostat) is a novel HDAC inhibitor in development for the treatment of peripheral T-cell lymphoma (PTCL).
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.
Company: Salix Pharmaceuticals, Inc.
Budesonide Foam is a high potency corticosteroid topical foam formulation in development for the treatment of ulcerative colitis.
Ragwitek (short ragweed pollen allergen extract)
Company: Merck & Co., Inc.
Ragwitek (short ragweed pollen allergen extract) is an investigational sublingual immunotherapy for the treatment of ragweed allergies.