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.

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.

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

cladribine Tablets

Company: Merck KGaA
Treatment for: Multiple Sclerosis

Cladribine (Tablets) is an investigational oral formulation of cladribine for reducing relapses in people with multiple sclerosis (MS).

FDA Accepts File for Cladribine Tablets as Potential Treatment for Relapsing Forms of Multiple Sclerosis - July 30, 2018
Merck: Regulatory Update on Cladribine Tablets - June 22, 2011
Merck Receives Complete Response Letter From FDA on Cladribine Tablets New Drug Application - March 2, 2011
Merck KGaA Announces Extension of FDA Priority Review Period for Cladribine Tablets for the Treatment of Relapsing Forms of MS - November 29, 2010
FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of Multiple Sclerosis - July 28, 2010
Merck Resubmits U.S. Application for Cladribine Tablets as a Potential MS Therapy - June 8, 2010
Merck KGaA Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application - November 30, 2009
Merck Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States - October 2, 2009

NKTR-181 (loxicodegol)

Company: Nektar Therapeutics
Treatment for: Pain

NKTR-181 (loxicodegol) is a novel mu-opioid agonist molecule designed to have a slow rate of entry into the brain thus reducing abuse potential and CNS-mediated side effects. NKTR-181 is in development for the treatment of chronic low back pain in adult patients new to opioid therapy.

buprenorphine Sublingual Spray

Company: Insys Therapeutics, Inc.
Treatment for: Pain

Buprenorphine Sublingual Spray is a novel sublingual spray formulation of the partial mu-opioid agonist buprenorphine in development for the management of moderate-to-severe acute pain.

INSYS Therapeutics Receives Complete Response Letter from FDA for Buprenorphine NDA - July 27, 2018
INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray - May 22, 2018
FDA Accepts New Drug Application (NDA) for Buprenorphine Sublingual Spray from INSYS Therapeutics - December 6, 2017
INSYS Therapeutics Files New Drug Application (NDA) for Buprenorphine Sublingual Spray with FDA - September 29, 2017

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 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

CAM2038 (buprenorphine)

Company: Camurus and Braeburn Pharmaceuticals
Treatment for: Opiate Dependence

CAM2038 (buprenorphine) is a long-acting partial opioid agonist formulation in development for the treatment of opioid use disorder.

Evenity (romosozumab)

Company: Amgen Inc.
Treatment for: Osteoporosis

Evenity (romosozumab) is an anti-sclerostin monoclonal antibody in development for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Amgen And UCB Resubmit Biologics License Application (BLA) For Evenity (romosozumab) To The US FDA - July 12, 2018
Amgen and UCB Receive Complete Response Letter from U.S. FDA for Evenity (romosozumab) BLA - July 16, 2017
Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab - September 26, 2016
Amgen and UCB Submit Biologics License Application for Romosozumab to the FDA - July 21, 2016

Krintafel (tafenoquine) Tablets

Company: GlaxoSmithKline
Treatment for: Malaria

Krintafel (tafenoquine) is an 8-aminoquinoline derivative antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria.

Dextenza (dexamethasone) Intracanalicular Depot

Company: Ocular Therapeutix, Inc.
Treatment for: Postoperative Ocular Inflammation

Dextenza (dexamethasone insert) is an investigational intracanalicular depot corticosteroid formulation designed to deliver sustained release dexamethasone to the ocular surface for up to 30 days after ophthalmic surgery for the treatment of post-surgical ocular inflammation and pain.

Ocular Therapeutix Announces NDA Resubmission of Dextenza - June 29, 2018
Ocular Therapeutix Receives Complete Response Letter from FDA for Dextenza NDA - July 11, 2017
Ocular Therapeutix Announces FDA Acceptance of NDA Resubmission for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery - February 22, 2017
Ocular Therapeutix Resubmits NDA for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery - January 23, 2017
Ocular Therapeutix Receives Complete Response Letter from FDA for its NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain - July 25, 2016
Ocular Therapeutix Announces FDA Acceptance of NDA Filing for Dextenza for the Treatment of Post-Surgical Ocular Pain - December 9, 2015
Ocular Therapeutix Submits NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain - September 28, 2015

glasdegib

Company: Pfizer Inc.
Treatment for: Acute Myeloid Leukemia

Glasdegib (PF-04449913) is an oral, smoothened (SMO) inhibitor that disrupts the hedgehog (Hh) pathway. Glasdegib is being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine.

FDA Grants Priority Review for Pfizer’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia - June 27, 2018

Scenesse (afamelanotide)

Company: Clinuvel Pharmaceuticals Ltd.
Treatment for: Erythropoietic Protoporphyria

Scenesse (afamelanotide) is a selective agonist of the melanocortin 1 receptor (MC1R) in development for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).

Historic New Drug Application for the use of Scenesse (afamelanotide) in Rare Metabolic Disorder Erythropoietic Protoporphyria (EPP) - June 25, 2018

ALXN1210 (ravulizumab)

Company: Alexion Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

ALXN1210 (ravulizumab) is an investigational long-acting C5 complement inhibitor in development for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S. - June 19, 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.

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 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

APL-130277 (apomorphine) Sublingual Film

Company: Sunovion Pharmaceuticals Inc.
Treatment for: Parkinson's Disease

APL-130277 (apomorphine sublingual film) is a novel formulation of the approved dopamine agonist apomorphine in development for the on-demand management of OFF episodes associated with Parkinson’s disease (PD).

Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277) - June 12, 2018

talazoparib

Company: Pfizer Inc.
Treatment for: Breast Cancer

Talazoparib is an oral poly ADP ribose polymerase (PARP) inhibitor in development for the treatment of germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation - June 7, 2018

lumateperone

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

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

Intra-Cellular Therapies Initiates Rolling Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia - June 6, 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 gastroparesis in women.

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

bremelanotide

Company: Palatin Technologies, Inc.
Treatment for: Hypoactive Sexual Desire Disorder

Bremelanotide is a melanocortin receptor agonist in development for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

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