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.
KIT-302 (amlodipine and celecoxib)
Company: Kitov Pharmaceuticals Holdings Ltd.
Treatment for: Hypertension, Osteoarthritis
KIT-302 (amlodipine and celecoxib) is a calcium channel blocker and nonsteroidal anti-inflammatory drug combination in development for the treatment of both hypertension and pain associated with osteoarthritis.
- Kitov Updates on KIT-302 New Drug Application - June 26, 2017
Company: Rigel Pharmaceuticals, Inc.
Treatment for: Immune Thrombocytopenia
Fostamatinib is an investigational oral spleen tyrosine kinase (SYK) inhibitor in development for the treatment of patients with chronic and persistent immune thrombocytopenia (ITP).
- FDA Accepts Rigel's New Drug Application for Tavalisse (fostamatinib disodium) for the Treatment of Chronic ITP - June 19, 2017
- Rigel Announces Tavalisse as Proprietary Name for Fostamatinib in the United States - April 27, 2017
- Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP - April 17, 2017
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Bictegravir, emtricitabine and tenofovir alafenamide is an investigational integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (FTC/TAF) combination in development for the treatment of HIV-1 infection in adults.
Vyndaqel (tafamidis meglumine)
Company: Pfizer Inc.
Treatment for: Transthyretin Familial Amyloid Polyneuropathy; Transthyretin Cardiomyopathy
Vyndaqel (tafamidis meglumine) is a transthyretin (TTR) dissociation inhibitor in development for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) and transthyretin cardiomyopathy (TTR-CM).
- Pfizer Receives FDA Fast Track Designation for Tafamidis for Transthyretin Cardiomyopathy - June 6, 2017
- Pfizer Announces Publication of New Analysis Showing Long-Term Therapy with Vyndaqel (tafamidis) Slowed Progression of Rare Neurodegenerative Disease - August 8, 2016
- FDA Issues Complete Response Letter For Pfizer's Tafamidis Meglumine New Drug Application - June 18, 2012
- FDA Advisory Committee Finds Data Support Effectiveness of Tafamidis Meglumine, Pfizer's Novel Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) - May 25, 2012
- FDA Accepts Pfizer's New Drug Application for Tafamidis Meglumine, a Novel, Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) - February 15, 2012
- Pfizer Receives Refusal To File Letter From U.S. FDA On Tafamidis New Drug Application - April 4, 2011
Company: Puma Biotechnology, Inc.
Treatment for: Breast Cancer -- Adjuvant
Neratinib is a potent irreversible tyrosine kinase inhibitor in development for the extended adjuvant treatment of HER2-positive early stage breast cancer.
- Puma Biotechnology Receives FDA Advisory Committee Support for Neratinib - May 24, 2017
- Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer - April 17, 2017
- Puma Biotechnology Announces FDA Acceptance of NDA for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer - September 20, 2016
- Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer - July 21, 2016
Yuvvexy (estradiol) - formerly TX-004HR
Company: TherapeuticsMD, Inc.
Treatment for: Dyspareunia
Yuvvexy (estradiol) is an investigational bio-identical 17β-estradiol softgel capsule vaginal formulation for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.
- TherapeuticsMD Receives Complete Response Letter from FDA for TX-004HR New Drug Application - May 8, 2017
- TherapeuticsMD Provides Additional Information on TX-004HR Regulatory Update - April 19, 2017
- TherapeuticsMD Provides TX-004HR Regulatory Update - April 10, 2017
- TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy (TX-004HR) - September 19, 2016
- TherapeuticsMD Announces New Drug Application Submission for Yuvvexy (TX-004HR) - July 7, 2016
Kevzara (sarilumab) Injection
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis
Kevzara (sarilumab) is an interleukin-6 receptor (IL-6R) antibody for the treatment of adults with rheumatoid arthritis.
- Sanofi and Regeneron Announce FDA Approval of Kevzara (sarilumab) for Rheumatoid Arthritis - May 22, 2017
- Sanofi and Regeneron Announce Kevzara (sarilumab) Biologics License Application Resubmission Accepted for Review by US FDA - April 28, 2017
- Sanofi and Regeneron Receive Complete Response Letter from FDA for Sarilumab, an Investigational Treatment for Rheumatoid Arthritis - October 28, 2016
- Sanofi and Regeneron Announce Sarilumab BLA Accepted for Review by FDA - January 8, 2016
DE-109 (sirolimus) Intravitreal Injection
Company: Santen Pharmaceutical Co., Ltd.
Treatment for: Uveitis
DE-109 (sirolimus), an mTOR inhibitor, is an investigational first-in-class targeted, immunoregulator in development for the of non-infectious uveitis of the posterior segment (NIU-PS).
Emflaza (deflazacort) Tablets and Oral Suspension
Company: PTC Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy
Emflaza (deflazacort) is a glucocorticoid for the treatment of Duchenne Muscular Dystrophy.
- PTC Therapeutics Completes Acquisition of Emflaza for the Treatment of Duchenne Muscular Dystrophy in the U.S. - April 20, 2017
- FDA Approves Emflaza (deflazacort) to treat Duchenne Muscular Dystrophy - February 9, 2017
- FDA Accepts Marathon Pharmaceuticals’ NDA for Deflazacort for the Treatment of Duchenne Muscular Dystrophy - August 10, 2016
- Marathon Pharmaceuticals Announces Submission of Deflazacort New Drug Application to the FDA - June 14, 2016
- Marathon Pharmaceuticals to Begin NDA Process for Deflazacort as a Potential Treatment for Patients with Duchenne Muscular Dystrophy - August 5, 2015
- Marathon Pharmaceuticals Receives FDA Fast Track Designation for Deflazacort as a Potential Treatment for Duchenne Muscular Dystrophy - January 19, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Acute Lymphoblastic Leukemia
CTL019 (tisagenlecleucel-T) is an investigational chimeric antigen receptor T cell (CAR-T) therapy in development for use in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Company: Eli Lilly and Company and Incyte Corporation
Treatment for: Rheumatoid Arthritis
Baricitinib is an oral selective JAK1 and JAK2 inhibitor in development for the treatment of rheumatoid arthritis.
- FDA Issues Complete Response Letter for Baricitinib - April 14, 2017
- U.S. FDA Extends Review Period For Baricitinib, An Investigational Rheumatoid Arthritis Treatment - January 13, 2017
- Lilly and Incyte Announce Submission of NDA to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis - January 19, 2016
Company: Icon Bioscience Inc.
Treatment for: Postoperative Ocular Inflammation
Dexycu (dexamethasone) is an investigational, long-acting, injectable corticosteroid formulation delivering dexamethasone into the anterior chamber of the eye for the treatment of inflammation associated with cataract surgery.
Zerviate (cetirizine hydrochloride) Ophthalmic Solution - formerly AC-170
Company: Nicox S.A.
Treatment for: Allergic Conjunctivitis
Zerviate (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist ophthalmic formulation for the treatment of ocular itching associated with allergic conjunctivitis.
- Nicox Receives FDA Approval of Zerviate (cetirizine ophthalmic solution) 0.24% - May 31, 2017
- Nicox Announces PDUFA Date for Zerviate NDA - April 11, 2017
- Nicox Resubmits AC-170 (Zerviate) NDA to the U.S. FDA - March 9, 2017
- Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170 - October 10, 2016
- U.S. FDA grants Priority Review for Nicox’s AC-170 New Drug Application - June 21, 2016
- Nicox submits New Drug Application for AC-170 to U.S. FDA - April 19, 2016
Rebinyn (coagulation factor IX (recombinant), glycopegylated) Injection
Company: Novo Nordisk
Treatment for: Hemophilia B
Rebinyn (coagulation factor IX (recombinant), glycopegylated is an extended-half-life recombinant DNA-derived coagulation factor IX concentrate for the treatment and control of bleeding episodes in patients with hemophilia B.
Vyxeos (cytarabine and daunorubicin) Injection
Company: Jazz Pharmaceuticals plc
Treatment for: Acute Myeloid Leukemia
Vyxeos (cytarabine and daunorubicin liposome injection) is an investigational nano-scale liposome co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio in development for the treatment of acute myeloid leukemia.
- Jazz Pharmaceuticals Completes Rolling Submission of New Drug Application for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia - April 3, 2017
- Jazz Pharmaceuticals Initiates Rolling NDA Submission for Vyxeos (CPX-351) Expects to Complete NDA Submission by Early 2017 - October 3, 2016