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: 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 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
Treatment for: Dyspareunia
Yuvvexy (estradiol) is a topical estrogen in an applicator-free, vaginal, softgel capsule formulation for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.
Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Carcinoid Syndrome
Telotristat etiprate is an oral tryptophan hydroxylase inhibitor in development for the treatment of carcinoid syndrome.
- FDA Extends PDUFA Date for Telotristat Etiprate for the Treatment of Carcinoid Syndrome - September 14, 2016
- Lexicon Announces FDA Priority Review of NDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome - May 31, 2016
- Lexicon Submits New Drug Application to FDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome - March 30, 2016
Company: Tesaro, Inc.
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Niraparib is an oral, poly ADP-ribose polymerase (PARP) inhibitor in development for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Rhopressa (netarsudil) Ophthalmic Solution
Company: Aerie Pharmaceuticals, Inc.
Treatment for: Glaucoma
Rhopressa (netarsudil ophthalmic solution) is a combination Rho Kinase and norepinephrine transporter (ROCK/NET) inhibitor in development for the treatment of glaucoma or ocular hypertension.
IDegLira (insulin degludec and liraglutide) Injection
Company: Novo Nordisk
Treatment for: Diabetes Type 2
IDegLira (insulin degludec and liraglutide) is a once-daily, single injection fixed combination of the basal insulin analogue insulin degludec (Tresiba), and the GLP-1 analogue liraglutide (Victoza), in development for the treatment of adults with type 2 diabetes.
Company: Array BioPharma
Treatment for: NRAS-Mutant Melanoma
Binimetinib is a late-stage small molecule MEK inhibitor in development for the treatment of advanced NRAS-mutant melanoma.
KedRAB (rabies immunoglobulin human)
Company: Kamada Ltd. and Kedrion S.p.A.
Treatment for: Rabies
KedRAB (human rabies immunoglobulin) is a human plasma derived anti-rabies immunoglobulin in development for the post-exposure treatment of rabies.
Company: Neurocrine Biosciences, Inc.
Treatment for: Tardive Dyskinesia
Ingrezza (valbenazine) is a novel, highly-selective VMAT2 inhibitor in development for the treatment of tardive dyskinesia.
Company: Ariad Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer
Brigatinib is an investigational anaplastic lymphoma kinase (ALK) inhibitor in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib.
Company: Mitsubishi Tanabe Pharma
Treatment for: Amyotrophic Lateral Sclerosis
Radicava (edaravone) is an investigational free radical scavenger that relieves the effects of oxidative stress, a likely factor in the onset and progression of amyotrophic lateral sclerosis.
Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism
Parsabiv (etelcalcetide) is a novel calcimimetic agent in clinical development for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis.
- Amgen Provides Update on Status of Parsabiv (Etelcalcetide) NDA Submitted to the U.S. FDA - August 24, 2016
- FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide - November 6, 2015
- Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) - August 25, 2015
Company: Clovis Oncology, Inc.
Treatment for: Ovarian Cancer
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed for the treatment of advanced mutant BRCA ovarian cancer.
iGlarLixi (insulin glargine and lixisenatide)
Treatment for: Diabetes Type 2
iGlarLixi (insulin glargine and lixisenatide) is an insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA) fixed-ratio combination in development for the treatment of adults with type 2 diabetes.
- Zealand Announces New Timelines for a U.S. FDA Decision on iGlarLixi, the Fixed-Ratio Combination of Lixisenatide (Adlyxin) and Lantus, for the Treatment of Type 2 Diabetes - August 20, 2016
- FDA Advisory Committee Recommends Approval of Sanofi Treatment for Adults With Type 2 Diabetes - May 25, 2016
- FDA Accepts Sanofi NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide - February 22, 2016
- Sanofi Submits NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide - December 23, 2015
AndexXa (andexanet alfa)
Company: Portola Pharmaceuticals, Inc.
Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors
AndexXa (andexanet alfa) is a recombinant protein designed to reverse the anticoagulant effect in patients treated with oral or injectable Factor Xa inhibitors.
- Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa (andexanet alfa) - August 18, 2016
- Portola Pharmaceuticals Announces BLA for Andexanet Alfa Accepted for Review by FDA - February 17, 2016
- Portola Pharmaceuticals Completes BLA Submission to U.S. Food and Drug Administration for Andexanet Alfa - December 18, 2015
Company: Soligenix, Inc.
Treatment for: Mucositis
SGX942 (dusquetide) is an innate defense regulator (IDR) in development for the treatment of oral mucositis.
Company: Marathon Pharmaceuticals, LLC
Treatment for: Duchenne Muscular Dystrophy
Deflazacort is a glucocorticoid in development for the treatment of Duchenne Muscular Dystrophy.
- 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: Pfizer Inc.
Treatment for: Transthyretin Familial Amyloid Polyneuropathy
Vyndaqel (tafamidis meglumine) is a transthyretin (TTR) dissociation inhibitor under investigation for the treatment of patients with Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP).
- 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: Merck & Co., Inc.
Treatment for: Diabetes Type 1, Diabetes Type 2
MK-1293 is an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes.