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.

Olinvo (oliceridine) Injection

Company: Trevena, Inc.
Treatment for: Pain

Olinvo (oliceridine) is a G protein biased ligand of the mu opioid receptor, a new class of opioid receptor modulator in development for the treatment of moderate-to-severe acute pain.

Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome - October 11, 2018
Trevena Announces FDA Acceptance for Review of New Drug Application for Olinvo (oliceridine) Injection - January 2, 2018
Trevena Announces Submission of New Drug Application to U.S. FDA for Olinvo (oliceridine injection) - November 2, 2017

Bryhali (halobetasol propionate) Lotion - formerly Jemdel

Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Bryhali (halobetasol propionate) is a high-potency topical steroid formulation in development for the treatment of plaque psoriasis.

Bausch Health's Bryhali (halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults - October 9, 2018
Ortho Dermatologics Announces U.S. FDA Filing Acceptance for Jemdel Plaque Psoriasis Treatment - February 14, 2018

siponimod

Company: Novartis
Treatment for: Multiple Sclerosis

Siponimod is an investigational, sphingosine-1-phosphate receptor modulator in development for the treatment of secondary progressive multiple sclerosis.

Novartis Announces FDA and EMA Filing Acceptance of Siponimod for Secondary Progressive Multiple Sclerosis (SPMS) - October 8, 2018

Barhemsys (amisulpride) Injection - formerly Baremsis

Company: Acacia Pharma
Treatment for: Nausea/Vomiting -- Postoperative

Barhemsys (amisulpride) is a dopamine antagonist in development for the management of post-operative nausea & vomiting (PONV).

FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys - October 8, 2018
Acacia Pharma Announces FDA Acceptance of NDA Filing For Baremsis for the Management of Post-Operative Nausea & Vomiting - January 4, 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.

Feraccru (ferric maltol)

Company: Shield Therapeutics plc
Treatment for: Iron Deficiency

Feraccru (ferric maltol) is a non-salt formulation of ferric iron in development for the treatment of iron deficiency.

Shield Therapeutics Announces Submission of a New Drug Application (NDA) for Feraccru for the treatment of Iron Deficiency - October 1, 2018

lumateperone

Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia

Lumateperone is first-in-class antipsychotic in development for the treatment of schizophrenia.

Valtoco (diazepam) Nasal Spray

Company: Neurelis, Inc.
Treatment for: Epilepsy

Valtoco (diazepam) is an investigational benzodiazepine nasal spray formulation in development for the treatment of epilepsy cluster seizures.

erdafitinib

Company: Janssen Pharmaceuticals, Inc.
Treatment for: Urothelial Carcinoma

Erdafitinib is an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) in development for the treatment of patients with locally advanced or metastatic urothelial cancer.

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer - September 18, 2018

tenapanor

Company: Ardelyx, Inc
Treatment for: Irritable Bowel Syndrome

Tenapanor is a first-in-class, small-molecule inhibitor of gastrointestinal NHE3 in development for the treatment of patients with irritable bowel syndrome with constipation (IBS-C).

Ardelyx Submits New Drug Application for Tenapanor for IBS-C - September 13, 2018

Inbrija (levodopa) Inhalation Powder

Company: Acorda Therapeutics, Inc.
Treatment for: Parkinson's Disease

Inbrija (levodopa) is an oral inhalation formulation of the approved drug levodopa in development as a treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.

Acorda Announces FDA Extends Inbrija NDA Review Period - September 13, 2018
Acorda Announces FDA Acceptance of New Drug Application for Inbrija (levodopa inhalation powder) - February 20, 2018
Acorda Resubmits New Drug Application for Inbrija (CVT-301, levodopa inhalation powder) - December 7, 2017
Acorda Receives Refusal to File Letter from FDA for Inbrija (CVT-301, levodopa inhalation powder) New Drug Application - August 29, 2017
Acorda Submits New Drug Application to U.S. Food and Drug Administration for Inbrija (CVT-301, Levodopa Inhalation Powder) - June 29, 2017

esketamine Nasal Spray

Company: Janssen Pharmaceuticals, Inc.
Treatment for: Depression

Esketamine is a rapid acting, investigational glutamate receptor modulator antidepressant in development for use in patients with treatment-resistant depression.

Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression - September 4, 2018

dasotraline

Company: Sunovion Pharmaceuticals Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Dasotraline is a dual dopamine and norepinephrine reuptake inhibitor (DNRI) in development for the treatment of attention deficit hyperactivity disorder (ADHD).

FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD - August 31, 2018
Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD - November 10, 2017
Sunovion Submits New Drug Application for Dasotraline to the FDA for the Treatment of Patients with ADHD - August 31, 2017

Waylivra (volanesorsen)

Company: Akcea Therapeutics, Inc.
Treatment for: Familial Chylomicronemia Syndrome

Waylivra (volanesorsen) is an antisense oligonucleotide apolipoprotein C-III (ApoC-III) inhibitor in development for the treatment of familial chylomicronemia syndrome (FCS).

Akcea and Ionis Receive Complete Response Letter for Waylivra from FDA - August 27, 2018
FDA Advisory Committee Votes in Favor of Waylivra (volanesorsen) for Treatment of Familial Chylomicronemia Syndrome - May 10, 2018
Akcea and Ionis Announce Acceptance of Marketing Applications in U.S., EU and Canada for Volanesorsen for the Treatment of FCS - November 15, 2017
Akcea and Ionis Announce Submission of New Drug Application for Volanesorsen to the U.S. FDA - August 31, 2017

stannsoporfin

Company: Mallinckrodt plc
Treatment for: Hyperbilirubinemia

Stannsoporfin is a heme oxygenase inhibitor in development for the treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.

Mallinckrodt Confirms Receipt of Stannsoporfin Complete Response Letter - August 22, 2018
Mallinckrodt Reports on FDA Joint Advisory Committee Meeting for Stannsoporfin for the Treatment of Newborns at Risk of Developing Severe Jaundice - May 3, 2018
Mallinckrodt Receives FDA Acceptance of Stannsoporfin New Drug Application Filing - February 23, 2018
Mallinckrodt Completes Stannsoporfin New Drug Application Filing - January 4, 2018

Esmya (ulipristal acetate)

Company: Allergan plc
Treatment for: Uterine Fibroids

Esmya (ulipristal acetate) is an oral selective progesterone receptor modulator (SPRM) in development for the treatment of uterine fibroids.

Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application - August 21, 2018
Allergan Announces FDA Has Extended The Ulipristal Acetate NDA Review Period To August 2018 - February 28, 2018
Allergan Announces that the FDA Accepts New Drug Application for Ulipristal Acetate for Uterine Fibroids - October 10, 2017

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’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

Duobrii (halobetasol propionate and tazarotene) Lotion - formerly IDP-118

Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Duobrii (halobetasol propionate and tazarotene) is a corticosteroid and retinoid combination in development for the topical treatment of plaque psoriasis.

Ortho Dermatologics Resubmits U.S. New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion - August 15, 2018
FDA Issues Complete Response Letter for Duobrii (halobetasol propionate and tazarotene) Lotion - June 18, 2018
Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-118, Novel Plaque Psoriasis Treatment - November 2, 2017

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 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

Nayzilam (midazolam) Nasal Spray

Company: UCB
Treatment for: Seizure Clusters

FDA Accepts New Drug Application (NDA) to Review Midazolam Nasal Spray, an Investigational Product for the Acute Treatment of Seizure Clusters - August 13, 2018

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