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: 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
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
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.
Company: Kythera Biopharmaceuticals, Inc.
Treatment for: Androgenetic Alopecia
KYTH-105 (setipiprant) is an oral prostaglandin D2 (PGD2) receptor antagonist in development for the treatment of androgenetic alopecia (AGA), or male pattern hair loss.
Company: Evofem, Inc.
Treatment for: Contraception
Amphora is a non-hormonal vaginal gel in development for use as a contraceptive.
Vesneo (latanoprostene bunod) Ophthalmic Solution
Company: Bausch+Lomb, and Nicox S.A.
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension
Vesneo (latanoprostene bunod ophthalmic solution) is a nitric oxide donating prostaglandin receptor agonist in development for the treatment of patients with open angle glaucoma or ocular hypertension.
Company: Mapp Biopharmaceutical, Inc.
Treatment for: Ebola Virus Disease
ZMapp is a combination of three chimeric monoclonal antibodies manufactured in the Nicotiana benthamiana tobacco plant. It has been used in the experimental treatment of Ebola virus disease.
ZTlido (lidocaine) Patch - formerly Ztilido
Company: Scilex Pharmaceuticals, Inc.
Treatment for: Postherpetic Neuralgia
ZTlido (lidocaine patch 1.8%) is a transdermal anesthetic formulation in development for the treatment of postherpetic neuralgia.
Company: Amicus Therapeutics
Treatment for: Fabry Disease
Migalastat (AT1001) is an investigational pharmacological chaperone in development for the treatment of Fabry 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 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
Abilify Digital (aripiprazole)
Company: Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health
Treatment for: Schizophrenia, Bipolar Disorder
Abilify Digital (aripiprazole) is a tablet formulation of an approved atypical antipsychotic embedded with an ingestible Proteus® sensor that communicates with a wearable sensor patch and a medical software application in development for measuring adherence in the treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.
Company: Takeda Pharmaceutical Company Limited
Treatment for: Multiple Myeloma
Ixazomib is an investigational oral proteasome inhibitor in development for the treatment of patients with relapsed and/or refractory multiple myeloma.
Company: Genentech, Inc.
Treatment for: Non-Small Cell Lung Cancer
Alectinib is an oral anaplastic lymphoma kinase (ALK) inhibitor in development for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Kanuma (sebelipase alfa)
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Lysosomal Acid Lipase Deficiency
Kanuma (sebelipase alfa) is an investigational enzyme replacement therapy for the treatment of lysosomal acid lipase deficiency (LAL-D).
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: Gilead Sciences, Inc.
Treatment for: HIV Infection
Emtricitabine/tenofovir alafenamide is an investigational nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination in development for the treatment of HIV-1 infection.
Company: Bristol-Myers Squibb Company and AbbVie
Treatment for: Multiple Myeloma
Empliciti (elotuzumab) is an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody in development for the combination treatment of multiple myeloma in patients who have received one or more prior therapies.