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: 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 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
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Huntington Disease, Tardive Dyskinesia
SD-809 (deutetrabenazine) is a vesicular monoamine 2 transporter (VMAT2) inhibitor in development for the treatment of chorea associated with Huntington disease.
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.
- Collegium Announces FDA Tentative Approval for Xtampza ER, a Novel Abuse-Deterrent Analgesic for Chronic Pain - November 9, 2015
- Collegium Provides Update on FDA Review of Xtampza ER, an Abuse-Deterrent Analgesic for the Treatment of Chronic Pain - October 12, 2015
- Collegium Announces FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain - September 11, 2015
- Collegium Announces FDA Advisory Committee Meeting for Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain - August 7, 2015
- Collegium Announces FDA Acceptance for Filing of NDA for Abuse-Deterrent Xtampza ER (oxycodone) - February 12, 2015
- Collegium Pharmaceutical Submits NDA for Xtampza ER (oxycodone) Abuse-Deterrent Analgesic - December 15, 2014
Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism
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.
Company: Merck & Co., Inc.
Treatment for: Reversal of Nondepolarizing Muscle Relaxants
Bridion (sugammadex) is an investigational novel selective relaxant binding agent (SRBA) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
- Merck Statement on FDA Advisory Committee Meeting for Bridion (sugammadex), Investigational Agent for the Reversal of Neuromuscular Blockade (NMB) Induced by Rocuronium or Vecuronium - November 6, 2015
- Merck Receives Complete Response Letter for Sugammadex Sodium Injection - April 28, 2015
- Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection - March 13, 2015
- Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection - September 23, 2013
- Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection - July 16, 2013
- Merck Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection - January 7, 2013
- U.S. FDA Issues Action Letter for Sugammadex - August 1, 2008
- FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent - March 12, 2008
- Schering-Plough Announces New Drug Application for Sugammadex Assigned Priority Review Status by U.S. FDA - January 3, 2008
Company: Acadia Pharmaceuticals Inc.
Treatment for: Parkinson’s Disease Psychosis
Nuplazid (pimavanserin) is a selective serotonin inverse agonist (SSIA) in development for the treatment of psychosis associated with Parkinson’s disease.
Company: Repros Therapeutics Inc.
Treatment for: Hypogonadism -- Male
Androxal (enclomiphene) is a non-steroidal estrogen receptor antagonist in development for secondary hypogonadism in overweight men wishing to restore normal testicular function.
- Repros Therapeutics Announces Cancellation of FDA Advisory Committee Meeting to Review Enclomiphene for the Treatment of Secondary Hypogonadism - October 29, 2015
- Repros Announces Date of FDA Advisory Committee Review of NDA - June 8, 2015
- Repros Announces November 30, 2015 PDUFA Goal Date for Enclomiphene Citrate NDA - April 15, 2015
- Repros Submits New Drug Application to FDA for Androxal - February 2, 2015
- Repros Reports Both Primary Endpoints Successfully Met in First Pivotal Study of Androxal - March 27, 2013
- Repros Submits Response to FDA Regarding Androxal Indication for Treatment of Hypogonadal Men Wishing to Preserve Fertility - February 8, 2010
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.
Company: AstraZeneca Pharmaceuticals LP
Treatment for: Gout
Lesinurad is a selective uric acid reabsorption inhibitor (SURI) in development for the combination treatment of hyperuricemia associated with gout.
Genvoya (cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide) Tablets
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide or E/C/F/TAF) is an antiretroviral combination for the treatment of HIV infection.
- FDA Approves Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) for HIV - November 5, 2015
- Gilead Announces Phase 3 Results for Genvoya (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV - October 22, 2015
Company: Shire plc
Treatment for: Dry Eye Disease
Lifitegrast is an investigational integrin antagonist for the topical treatment of dry eye disease.
In October 2015, Shire plc announced the U.S. Food and Drug Administration (FDA) had requested an additional clinical study as part of a complete response letter (CRL) to the company’s new drug application for lifitegrast.
- 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
Treatment for: Diabetes Type 2
Dapagliflozin and saxagliptin is an investigational sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor fixed-dose combination for the treatment of adult patients with type 2 diabetes.
In October 2015, AstraZeneca announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for the dapagliflozin and saxagliptin combination had not been approved.
Company: BioMarin Pharmaceutical Inc.
Treatment for: Duchenne Muscular Dystrophy
Drisapersen is an investigational antisense oligonucleotide in development for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping.
- 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: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease
Xadago (safinamide) is an alpha-aminoamide in development as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease.
- Xadago (safinamide) NDA Late-Cycle Review Meeting Completed with U.S. FDA - September 30, 2015
- Xadago (safinamide) NDA Accepted for Filing by the U.S. FDA - March 2, 2015
- Safinamide NDA Re-submitted to the U.S. FDA - December 29, 2014
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).
Treatment for: Diabetes Type 2
Lyxumia (lixisenatide) is a once-daily prandial GLP-1 receptor agonist in development for the treatment of adults with type 2 diabetes mellitus.
- Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA - September 29, 2015
- Sanofi Reports Positive Top-Line Results In Second Pivotal Lixilan Phase III Study - September 14, 2015
- Sanofi's Lyxumia (lixisenatide) Demonstrated Cardiovascular Safety in People With Type 2 Diabetes and High CV Risk - June 8, 2015
- Lyxumia (Lixisenatide) Meets Co-Primary Endpoints in GetGoal Duo-2 Trial - June 6, 2015
- Sanofi Announces Top-Line Results for Cardiovascular Outcomes Study of Lyxumia (Lixisenatide) - March 19, 2015
- Sanofi's Lyxumia (lixisenatide) Showed More Pronounced After-Test-Meal Blood Sugar Lowering than Liraglutide when Both were Added to Insulin Glargine - June 14, 2014
- Sanofi Provides Update on Lixisenatide New Drug Application in U.S. - September 12, 2013
- Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA - February 19, 2013
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.
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 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