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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.

Gimoti (metoclopramide) Nasal Spray

Company: Evoke Pharma, Inc.
Treatment for: Gastroparesis

Gimoti (metoclopramide) is an intranasal formulation of the approved drug metoclopramide in development for the treatment of symptoms associated with diabetic gastroparesis in women.


Company: Eisai Co., Ltd.
Treatment for: Insomnia

Lemborexant is dual orexin receptor antagonist (DORA) in development for the treatment of insomnia.


Company: Allergan plc
Treatment for: Migraine

Ubrogepant is a potent, orally-administered CGRP receptor antagonist in development for the acute treatment of migraine.


Company: TB Alliance
Treatment for: Tuberculosis -- Resistant

Pretomanid is a nitroimidazooxazine in development for use in combination with bedaquiline and linezolid (the BPaL regimen) for the treatment of extensively drug-resistant (XDR) tuberculosis (TB), treatment intolerant multidrug-resistant (MDR) TB, and treatment non-responsive MDR-TB.

FMX101 (minocycline) Foam

Company: Foamix Pharmaceuticals
Treatment for: Acne

FMX101 (minocycline) is a topical foam formulation of minocycline in development for the treatment of moderate-to-severe acne vulgaris.


Company: Celgene Corporation
Treatment for: Myelofibrosis

Fedratinib is a highly selective JAK2 inhibitor in development for the treatment of patients with myelofibrosis.

Rexista (oxycodone hydrochloride) Extended-Release Tablets

Company: Intellipharmaceutics International Inc.
Treatment for: Pain

Rexista (oxycodone hydrochloride extended release) is an abuse and alcohol-deterrent controlled-release formulation of oxycodone hydrochloride in development for the relief of moderate to severe pain.


Company: Bayer
Treatment for: Prostate Cancer

Darolutamide is an investigational, non-steroidal androgen receptor antagonist in development for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

Vumerity (diroximel fumarate)

Company: Alkermes plc and Biogen Inc.
Treatment for: Multiple Sclerosis

Vumerity (diroximel fumarate) is a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS).


Company: AbbVie Inc.
Treatment for: Rheumatoid Arthritis

Upadacitinib is a JAK1-selective inhibitor in development for the treatment of adult patients with moderate to severe rheumatoid arthritis.


Company: Harmony Biosciences, LLC
Treatment for: Narcolepsy

Pitolisant is a potent and highly selective histamine 3 (H₃) receptor antagonist/inverse agonist in development for the treatment of excessive daytime sleepiness (EDS) and/or cataplexy in adult patients with narcolepsy.

Spravato (esketamine) Nasal Spray

Company: Janssen Pharmaceuticals, Inc.
Treatment for: Treatment-Resistant Depression

Spravato (esketamine) is a rapid acting, nasal spray formulation of a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for use in adults with treatment-resistant depression.

Fintepla (fenfluramine)

Company: Zogenix, Inc.
Treatment for: Dravet Syndrome

Fintepla ((ZX008, low-dose fenfluramine) is an amphetamine derivative in development for the treatment of seizures associated with Dravet syndrome.


Company: Daiichi Sankyo Company, Limited
Treatment for: Tenosynovial Giant Cell Tumor

Pexidartinib is a CSF1R (colony stimulating factor-1 receptor) inhibitor in development for the treatment of symptomatic tenosynovial giant cell tumor (TGCT).

Remoxy ER (oxycodone)

Company: Pain Therapeutics, Inc.
Treatment for: Pain

Remoxy ER (oxycodone) is a long-acting, abuse-resistant, narcotic analgesic formulation in development for the treatment of moderate to severe chronic pain.

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

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