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

ozanimod

Company: Celgene Corporation
Treatment for: Multiple Sclerosis, Ulcerative Colitis

Ozanimod is an investigational selective sphingosine 1-phosphate (S1P) 1 and 5 receptor modulator in development for the treatment of patients with relapsing multiple sclerosis, and ulcerative colitis.

• Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis - March 25, 2019

Zynquista (sotagliflozin)

Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Diabetes Type 1

Zynquista (sotagliflozin) is an investigational dual SGLT1 and SGLT2 inhibitor for use in combination with insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

• FDA Issues Complete Response Letter for Zynquista (sotagliflozin) - March 25, 2019
• FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes - January 17, 2019
• FDA to Review Zynquista (sotagliflozin) as Potential Treatment for Type 1 Diabetes - May 22, 2018
• Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults with Type 1 Diabetes - March 26, 2018

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.

• Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application - March 14, 2019
• Karyopharm Announces Outcome of FDA Advisory Committee Meeting Reviewing Selinexor for the Treatment of Patients with Triple Class Refractory Multiple Myeloma - February 27, 2019
• Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma - November 7, 2018
• U.S. FDA Accepts Karyopharm’s New Drug Application for Selinexor and Grants Priority Review - October 5, 2018
• Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma - July 18, 2018

lemborexant

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

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

• Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia - March 12, 2019
• New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States - January 15, 2019

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.

• Foamix Announces FDA Acceptance of New Drug Application for FMX101 Minocycline Foam for the Treatment of Moderate-to-Severe Acne - March 7, 2019
• Foamix Submits New Drug Application to U.S. FDA Seeking Approval of FMX101 in Treatment of Moderate-to-Severe Acne - December 21, 2018

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.

• Intellipharmaceutics Announces Resubmission of New Drug Application to the U.S. FDA for its Oxycodone ER - March 4, 2019
• Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista NDA - September 25, 2017
• Intellipharmaceutics Announces FDA Acceptance for Filing of NDA for Rexista (oxycodone hydrochloride extended release) Abuse Deterrent Opioid Analgesic - February 2, 2017
• Intellipharmaceutics Submits NDA for Rexista (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain - November 25, 2016

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).

• Alkermes and Biogen Announce U.S. Food and Drug Administration Acceptance of Diroximel Fumarate New Drug Application for Multiple Sclerosis - February 25, 2019
• Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis - December 17, 2018

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.

• AbbVie Announces New Drug Application Accepted for Priority Review by FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis - February 19, 2019
• AbbVie Submits New Drug Application to U.S. FDA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis - December 20, 2018

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.

• Sarepta Announces FDA Acceptance of Golodirsen (SRP-4053) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53 - February 14, 2019
• Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53 - December 20, 2018
• Sarepta Therapeutics Announces Plan to Submit a New Drug Application (NDA) for Accelerated Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy (DMD) Amenable to Skipping Exon 53 - March 12, 2018

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

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