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.
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.
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).
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.
Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia
Lumateperone is first-in-class antipsychotic in development for the treatment of schizophrenia.
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.
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.
Duaklir (aclidinium bromide and formoterol fumarate)
Company: Circassia Pharmaceuticals plc
Treatment for: Chronic Obstructive Pulmonary Disease
Duaklir Pressair (aclidinium bromide and formoterol fumarate) is a long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA) fixed dose combination maintenance bronchodilator in development for the treatment of COPD.
Company: Sage Therapeutics
Treatment for: Postpartum Depression
Brexanolone (SAGE-547) is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors in development for the treatment of postpartum depression (PPD).
- Sage Therapeutics Announces FDA Acceptance of NDA Filing and Grant of Priority Review for Brexanolone IV in the Treatment of Postpartum Depression - May 30, 2018
- Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression - April 23, 2018
Company: Kyowa Hakko Kirin Co., Ltd.
Treatment for: Mycosis Fungoides; Sézary Syndrome
Mogamulizumab is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) in development for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL).
- Kyowa Hakko Kirin Announces FDA Notification of PDUFA Action Date Extension for Mogamulizumab - May 30, 2018
- Kyowa Hakko Kirin Announces FDA Acceptance for Filing and Priority Review Designation of Mogamulizumab Biologics License Application - November 28, 2017
- FDA Grants Breakthrough Therapy Designation for Mogamulizumab for the Treatment of Mycosis Fungoides and Sézary Syndrome - August 25, 2017
Company: Loxo Oncology, Inc.
Treatment for: Solid Tumors
Larotrectinib is an oral selective tropomyosin receptor kinase (TRK) inhibitor in clinical development for the treatment solid tumors harboring NTRK-fusion proteins.
- FDA Accepts Larotrectinib New Drug Application and Grants Priority Review - May 29, 2018
- Loxo Oncology Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Larotrectinib for the Treatment of TRK Fusion Cancer - March 26, 2018
- Loxo Oncology Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Larotrectinib for the Treatment of TRK Fusion Cancers - December 20, 2017
Company: Astellas Pharma Inc.
Treatment for: Acute Myeloid Leukemia
Gilteritinib is an inhibitor of the tyrosine kinases FLT3/AXL in development for the treatment of patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML).
- U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) - May 29, 2018
- Astellas Submits New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia - April 23, 2018
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 dependence.
- Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder - May 28, 2018
- Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot - January 21, 2018
- Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder - November 1, 2017
- Camurus Announces that FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder - September 18, 2017
- Camurus and Braeburn Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder - July 20, 2017
DSUVIA (sufentanil) Sublingual Tablets - formerly ARX-04
Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain
DSUVIA (sufentanil) is an investigational synthetic opioid analgesic formulation administered sublingually for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting.
- AcelRx Announces FDA Acceptance of NDA for DSUVIA - May 24, 2018
- AcelRx Resubmits New Drug Application for DSUVIA - May 9, 2018
- AcelRx Announces Receipt of Type A FDA Meeting Minutes and Plans to Resubmit the DSUVIA New Drug Application in Q2 2018 - March 8, 2018
- AcelRx Pharmaceuticals Receives Complete Response Letter from the FDA for DSUVIA NDA - October 12, 2017
- AcelRx Pharmaceuticals' New Drug Application for DSUVIA Accepted for Filing - February 27, 2017
- AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA in the United States, for the Treatment of Moderate-to-Severe Acute Pain - January 8, 2017
- AcelRx Pharmaceuticals Submits New Drug Application for ARX-04 for the Treatment of Moderate-To-Severe Acute Pain - December 13, 2016
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Migraine Prophylaxis
Fremanezumab is a fully-humanized monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) ligand in development for the preventive treatment of migraine.
- Teva Confirms September PDUFA Date for Fremanezumab - May 23, 2018
- FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program - December 18, 2017
- Teva Announces Submission of Biologics License Application for Fremanezumab to the U.S. FDA - October 17, 2017
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 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
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.
Ryaltris (mometasone furoate and olopatadine hydrochloride) Nasal Spray
Company: Glenmark Pharmaceuticals, Inc.
Treatment for: Allergic Rhinitis
Ryaltris (mometasone and olopatadine) is an investigational steroid and antihistamine fixed-dose combination nasal spray in development as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older.
Twirla (ethinyl estradiol and levonorgestrel) Transdermal System
Company: Agile Therapeutics, Inc.
Treatment for: Contraception
Twirla (ethinyl estradiol and levonorgestrel transdermal system) is an investigational low-dose combined hormonal contraceptive patch in development as a form of birth control. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch.
- Agile Therapeutics, Inc. Provides Regulatory Update on Twirla (AG200-15) for the Prevention of Pregnancy - May 18, 2018
- Agile Therapeutics, Inc. Receives a Complete Response Letter from the FDA for Twirla (AG200-15) for the Prevention of Pregnancy - December 22, 2017
- Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla - July 27, 2017
- Agile Therapeutics Resubmits New Drug Application for its Transdermal Contraceptive Patch, Twirla - June 27, 2017
Roclatan (latanoprost and netarsudil)
Company: Aerie Pharmaceuticals, Inc.
Roclatan (latanoprost/netarsudil ophthalmic solution) is a fixed dose combination of two approved drugs -- the prostaglandin analog latanoprost (Xalatan) and Rho kinase inhibitor netarsudil (Rhopressa) -- in development for the treatment of patients with glaucoma or ocular hypertension.