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.

Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA - March 14, 2019
Evoke Pharma’s Gimoti NDA Accepted for FDA Review - August 16, 2018
Evoke Announces FDA Submission of New Drug Application for Gimoti - June 4, 2018
FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application - March 5, 2018

selinexor

Company: Karyopharm Therapeutics Inc.
Treatment for: Multiple Myeloma

Selinexor (KPT-330) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist in development for the treatment of patients with penta-refractory multiple myeloma.

lemborexant

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

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

ubrogepant

Company: Allergan plc
Treatment for: Migraine

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

Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine - March 11, 2019

pretomanid

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.

TB Medicine Pretomanid Enters Regulatory Review Process in the United States - March 8, 2019

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.

fedratinib

Company: Celgene Corporation
Treatment for: Myelofibrosis

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

U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis - March 5, 2019

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.

darolutamide

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).

Bayer Completes Rolling Submission of NDA for Investigational Drug Darolutamide for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC) - February 27, 2019

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).

upadacitinib

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.

entrectinib

Company: Genentech, Inc.
Treatment for: Solid Tumors

Entrectinib is a selective tyrosine kinase inhibitor in development for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors.

FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib - February 18, 2019
Ignyta Receives FDA Orphan Drug Designation for Entrectinib for Treatment of NTRK Fusion-Positive Solid Tumors - July 10, 2017
Ignyta Granted Breakthrough Therapy Designation for Entrectinib by U.S. Food and Drug Administration - May 15, 2017
Ignyta Announces Collaboration with UCSF For Clinical Trial of Entrectinib - July 6, 2015
Ignyta Receives Orphan Drug Designation and Rare Pediatric Disease Designation for Entrectinib - December 29, 2014

golodirsen

Company: Sarepta Therapeutics, Inc.
Treatment for: Muscular Dystrophy

Golodirsen is a phosphordiamidate morpholino oligimer in development for the treatment of patients with Duchenne muscular dystrophy (DMD) who have genetic mutations subject to skipping exon 53 of the DMD gene.

iclaprim Intravenous Injection

Company: Motif Bio plc
Treatment for: Skin and Structure Infection

Iclaprim is an investigational broad-spectrum diaminopyrimidine antibiotic in development for the treatment of acute bacterial skin and skin structure infections (ABSSSIs).

Motif Bio Receives Complete Response Letter From The FDA - February 14, 2019
Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections - August 14, 2018
Motif Bio Submits NDA for Iclaprim - June 14, 2018
First Patient Dosed in Iclaprim Phase 3 Trials to Treat Skin Infections - March 2, 2016
FDA Grants Fast Track Designation for Iclaprim - September 3, 2015
FDA QIDP Designation for Motif’s Lead Antibiotic Candidate Iclaprim for ABSSSI - July 22, 2015
FDA Issues Complete Response Letter for Iclaprim - January 20, 2009
Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome - November 21, 2008
Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008 - October 14, 2008
Arpida Announces FDA Acceptance of the Iclaprim New Drug Application - May 16, 2008
Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections - March 19, 2008

pitolisant

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.

Harmony Biosciences Announces File Acceptance Of Its New Drug Application For Pitolisant - February 12, 2019

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.

FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression - March 5, 2019
FDA Advisory Committee Recommends Approval of Spravato (esketamine) Nasal Spray for Adults with Treatment-Resistant Depression - February 12, 2019
Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression - September 4, 2018

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.

Zogenix Submits New Drug Application to U.S. Food & Drug Administration for Fintepla for the Treatment of Dravet Syndrome - February 6, 2019

pexidartinib

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).

FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor - February 5, 2019

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.

Pain Therapeutics Announces Feedback from Recent Meeting With FDA on Remoxy - February 5, 2019
Complete Response Letter Issued for Remoxy - August 6, 2018
Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER - June 26, 2018
FDA Accepts Remoxy NDA For Review - March 1, 2018
Pain Therapeutics Resubmits New Drug Application for Remoxy ER, an Abuse-Deterrent, Extended-Release Drug Candidate for the Treatment of Chronic Pain - February 13, 2018
Pain Therapeutics Receives Complete Response Letter for Remoxy ER - September 26, 2016
FDA Accepts Remoxy NDA for Review - April 12, 2016
Pain Therapeutics Resubmits Remoxy New Drug Application to the U.S. Food and Drug Administration - March 29, 2016
Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII - October 27, 2014
FDA Complete Response Letter Received for Remoxy - June 24, 2011
Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011 - January 27, 2011
King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for Remoxy - December 27, 2010
Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy - December 11, 2008
Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy - June 10, 2008

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