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: Synergy Pharmaceuticals Inc.
Treatment for: Constipation -- Chronic, Irritable Bowel Syndrome
Plecanatide is a uroguanylin analog in late-stage clinical development for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).
Company: AstraZeneca and Valeant Pharmaceuticals International, Inc.
Treatment for: Plaque Psoriasis
Brodalumab is a human anti-interleukin-17-receptor monoclonal antibody in development for the treatment of plaque psoriasis.
Company: Shire plc
Treatment for: Dry Eye Disease
Lifitegrast is an investigational integrin antagonist for the topical treatment of dry eye disease.
- Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA - January 25, 2016
- Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial - October 16, 2015
- U.S. FDA Grants Priority Review to Lifitegrast NDA for the Treatment of Dry Eye Disease in Adults - April 9, 2015
- Shire Submits NDA to the FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults - March 2, 2015
- Shire Plans to Submit a New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults - May 16, 2014
ABP 501 (adalimumab)
Company: Amgen Inc.
Treatment for: Plaque Psoriasis, Rheumatoid Arthritis
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody approved as Humira for the treatment of various inflammatory diseases including plaque psoriasis and rheumatoid arthritis.
- FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501 - January 25, 2016
- Amgen's First Biosimilar Biologics License Application for ABP 501 Submitted to FDA - November 25, 2015
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.
Sustol (granisetron) - formerly APF530
Company: A.P. Pharma, Inc.
Treatment for: Nausea/Vomiting -- Chemotherapy Induced
Sustol (granisetron) is a long-acting 5-HT3 antagonist formulation in development for the prevention of chemotherapy-induced nausea and vomiting.
- Heron Therapeutics Notified by FDA That It Will Not Take Action on Sustol New Drug Application by the PDUFA Date - January 15, 2016
- Heron Therapeutics Provides Update on Sustol Resubmission - January 27, 2014
- FDA Rejects A.P. Pharma's Cancer Drug - April 2, 2013
- A.P. Pharma Receives FDA Complete Response Letter for APF530 - March 29, 2013
- A.P. Pharma Announces PDUFA Action Date for APF530 New Drug Application Resubmission - October 16, 2012
- A.P. Pharma Provides Regulatory Update on APF530 NDA - April 25, 2011
- A.P. Pharma Receives FDA Complete Response Letter for APF530 - March 19, 2010
- A.P. Pharma Announces FDA Acceptance of APF530 New Drug Application for Chemotherapy-Induced Nausea and Vomiting - July 20, 2009
- A.P. Pharma Submits New Drug Application for APF530 in Chemotherapy-Induced Nausea and Vomiting - May 18, 2009
Company: BioMarin Pharmaceutical Inc.
Treatment for: Duchenne Muscular Dystrophy
Kyndrisa (drisapersen) is an investigational antisense oligonucleotide in development for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping.
- FDA Issues Complete Response Letter for Kyndrisa for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping - January 14, 2016
- BioMarin Announces That FDA Has Advised it Will Not Take Action on the Kyndrisa (drisapersen) NDA by the PDUFA Date - December 18, 2015
- BioMarin Announces FDA Advisory Committee to Review Drisapersen for Treatment of Patients With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping - October 15, 2015
- BioMarin Receives Rare Pediatric Disease Designation From FDA for Drisapersen for the Potential Treatment of Duchenne Muscular Dystrophy - August 19, 2015
- BioMarin Announces FDA Accepts Drisapersen NDA for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping - June 29, 2015
- BioMarin Completes Rolling NDA Submission to FDA for Drisapersen for Duchenne Muscular Dystrophy - April 27, 2015
- Prosensa Begins NDA Submission for Drisapersen to treat Duchenne Muscular Dystrophy - October 10, 2014
- Prosensa Announces Regulatory Path Forward for Drisapersen as a Potential Treatment for DMD - June 3, 2014
Company: AbbVie Inc.
Treatment for: Chronic Lymphocytic Leukemia
Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor in development for the treatment of patients with chronic lymphocytic leukemia (CLL).
Company: Titan Pharmaceuticals, Inc.
Treatment for: Opiate Dependence
Probuphine (buprenorphine) is an opioid partial agonist subdermal implant in development for the treatment of opioid dependence.
- Titan Pharmaceuticals And Braeburn Pharmaceuticals Announce FDA Advisory Committee Recommends Approval Of Probuphine - January 12, 2016
- Titan Pharmaceuticals Announces FDA's Acceptance of Resubmission of NDA for Probuphine - September 28, 2015
- Titan Pharmaceuticals Reports Positive Results from Phase 3 Study of Probuphine for Opioid Addiction - June 8, 2015
- Titan Pharmaceuticals Receives Complete Response Letter From the FDA for Probuphine New Drug Application - May 1, 2013
- Titan Pharmaceuticals Announces Date of FDA Advisory Committee Review of Probuphine for the Treatment of Opioid Dependence - February 27, 2013
- Titan Pharmaceuticals Announces Submission of New Drug Application for Probuphine for the Treatment of Opioid Dependence - October 29, 2012
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis
Sarilumab is an investigational, human monoclonal antibody directed against the IL-6 receptor in development for the treatment of patients with rheumatoid arthritis.
- Sanofi and Regeneron Announce Sarilumab BLA Accepted for Review by FDA - January 8, 2016
crisaborole Topical Ointment
Company: Anacor Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis
Crisaborole is a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the treatment of mild-to-moderate atopic dermatitis.
Company: CTI BioPharma Corp.
Treatment for: Myelofibrosis
Pacritinib is an investigational oral JAK2/FLT3 multikinase inhibitor in development for the treatment of patients with myelofibrosis.
- CTI BioPharma and Baxalta Complete Submission of NDA for Pacritinib for Unmet Medical Need in Myelofibrosis - January 5, 2016
- CTI BioPharma Initiates Rolling Submission of NDA for Pacritinib for the Treatment of Patients with Myelofibrosis - November 23, 2015
- CTI BioPharma To Submit NDA For Pacritinib In Q4 Based Primarily On Data From Single Pivotal Persist-1 Trial - September 23, 2015
Company: Gilead Sciences, Inc.
Treatment for: Chronic Hepatitis C
Sofosbuvir/velpatasvir is an investigational nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination in development for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.
- Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection - January 4, 2016
- Gilead Submits NDA to U.S. FDA for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C - October 28, 2015
Treatment for: Diabetes Type 2
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.
Firdapse (amifampridine phosphate)
Company: Catalyst Pharmaceuticals, Inc.
Treatment for: Lambert Eaton Myasthenic Syndrome (LEMS); Congenital Myasthenic Syndromes (CMS)
Firdapse (amifampridine phosphate) is a neuronal potassium channel blocker in development for the treatment of Lambert Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS).
Company: Clovis Oncology, Inc.
Treatment for: Non-Small Cell Lung Cancer
Rociletinib is a mutant-selective inhibitor of epidermal growth factor receptor (EGFR) in development for the treatment of metastatic EGFR T790M-mutant non–small cell lung cancer (NSCLC).
- Clovis Oncology Receives Notification of PDUFA Extension for Rociletinib - December 15, 2015
- Clovis Oncology Announces Regulatory Update for Rociletinib NDA Filing - November 16, 2015
- Clovis Oncology Announces U.S. and E.U. Regulatory Milestones for Rociletinib in the Treatment of Advanced EGFR-Mutant T790M+ Non-Small Cell Lung Cancer - November 15, 2015
- Clovis Oncology Submits NDA for Rociletinib for the Treatment of Advanced EGFR-Mutant T790M+ Non-small Cell Lung Cancer - August 3, 2015
- Clovis Oncology Initiates Rolling NDA Submission for Rociletinib in Advanced EGFR-Mutant Non-Small Cell Lung Cancer - July 1, 2015
Arymo ER (morphine sulfate) Extended-Release Tablets
Company: Egalet Corporation
Treatment for: Pain
Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation in development for the management of severe pain.
- Egalet Submits NDA for Arymo ER (Morphine Sulfate) Extended-Release Tablets - December 15, 2015
Dextenza (dexamethasone) Intracanalicular Depot
Company: Ocular Therapeutix, Inc.
Treatment for: Postoperative Ocular Inflammation
Dextenza (dexamethasone) is an investigational intracanalicular depot corticosteroid formulation delivering sustained release dexamethasone to the ocular surface for up to 30 days for the treatment of post-surgical ocular inflammation and pain.