Skip to Content

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.

Xadago (safinamide)

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.


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).


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.

KYTH-105 (setipiprant)

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.

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).

Nuplazid (pimavanserin)

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.

emtricitabine and tenofovir alafenamide

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.

Empliciti (elotuzumab)

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.

See also: Generic Approvals, New Drug Approvals, Recent Additions to, Alphabetical Listing of all New Drug Applications, FDA Approval Process

Older articles