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.
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.
TX-001HR (estradiol and progesterone)
Company: TherapeuticsMD, Inc.
Treatment for: Perimenopausal Symptoms
TX-001HR is an investigational bio-identical hormone combination of estradiol and progesterone in development for the treatment of moderate-to-severe vasomotor symptoms due to menopause.
DSUVIA (sufentanil) Sublingual Tablets - formerly ARX-04
Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain
DSUVIA (sufentanil) is a synthetic opioid analgesic administered sublingually by a healthcare professional for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting.
- 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
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.
- FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application - March 5, 2018
Company: Shire plc
Treatment for: Chronic Idiopathic Constipation
Prucalopride is a selective serotonin type 4 (5‑HT4) receptor agonist in development for the treatment of chronic idiopathic constipation (CIC) in adults.
Company: Jazz Pharmaceuticals plc
Treatment for: Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome
Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).
- Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea - March 2, 2018
- Jazz Pharmaceuticals Submits New Drug Application for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnea - December 21, 2017
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.
- 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
Company: Allergan plc
Treatment for: Uterine Fibroids
Ulipristal acetate is an oral selective progesterone receptor modulator (SPRM) in development for the treatment of uterine fibroids.
Company: Shionogi & Co., Ltd.
Treatment for: Thrombocytopenia
Lusutrombopag is an investigational, once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist in development for the treatment of thrombocytopenia in patients with chronic liver disease who are at increased risk for bleeding associated with invasive procedures.
Company: Tetraphase Pharmaceuticals, Inc.
Treatment for: Intraabdominal Infection
Eravacycline is a fluorocycline antibiotic in development for the treatment of complicated intra-abdominal infections.
- Tetraphase Pharmaceuticals Announces FDA Acceptance for Filing of its NDA Submission for Eravacycline for the Treatment of Complicated Intra-Abdominal Infections - February 27, 2018
- Tetraphase Pharmaceuticals Announces Submission of New Drug Application to FDA for Eravacycline for the Treatment of Complicated Intra-Abdominal Infections (cIAI) - January 2, 2018
lanadelumab - formerly SHP643
Company: Shire plc
Treatment for: Hereditary Angioedema
Lanadelumab is an investigational fully human monoclonal antibody that inhibits plasma kallikrein in development as a treatment for the prevention of angioedema attacks in patients with hereditary angioedema.
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 Receives FDA Acceptance of Stannsoporfin New Drug Application Filing - February 23, 2018
- Mallinckrodt Completes Stannsoporfin New Drug Application Filing - January 4, 2018
Amphora (L-lactic acid, citric acid, and potassium bitartrate) Vaginal Gel
Company: Evofem, Inc.
Treatment for: Contraception
Amphora (L-lactic acid, citric acid, and potassium bitartrate) is a non-hormonal vaginal gel in development for use as a contraceptive, and for the prevention of urogenital chlamydia in women.
- Evofem Biosciences Receives Fast Track Designation for Amphora for Prevention of Chlamydia - February 21, 2018
- Evofem, Inc. Announces FDA Acceptance of New Drug Application for Amphora as a Contraceptive - September 22, 2015
- Evofem, Inc. Submits NDA to U.S. FDA for Amphora as a Contraceptive - July 6, 2015
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 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
Company: PTC Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy
Translarna (ataluren) is a protein restoration therapy in development for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).
- PTC Therapeutics Receives Formal Dispute Resolution Request Decision from the FDA's Office of New Drugs - February 20, 2018
- PTC Therapeutics Receives Complete Response Letter for Ataluren's NDA - October 25, 2017
- PTC Therapeutics Announces FDA Acknowledgment of New Drug Application Filing for Translarna for the Treatment of Nonsense Mutation Duchenne Muscular Dystrophy - March 6, 2017
- PTC Therapeutics Provides Regulatory Update on Translarna (ataluren) for Nonsense Mutation Duchenne Muscular Dystrophy - October 17, 2016
- PTC Receives Refuse to File Letter from FDA for Translarna (ataluren) - February 23, 2016
- PTC Therapeutics Begins Rolling NDA Submission to the FDA for Translarna to Treat Duchenne Muscular Dystrophy - December 23, 2014
Vitaros (alprostadil) Cream - formerly Alprox-TD
Company: Apricus Biosciences, Inc.
Treatment for: Erectile Dysfunction
Vitaros (alprostadil) is a topical vasodilator cream in development for the treatment of erectile dysfunction.
- Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros - February 16, 2018
- Apricus Biosciences Files NDA Resubmission for Vitaros - August 29, 2017
- Apricus Biosciences Provides Update on Vitaros NDA Following Receipt of FDA Feedback - November 18, 2016
- NexMed Discusses End of Review Meeting for Vitaros - October 20, 2008
- NexMed Receives FDA Response for Topical ED Product - July 23, 2008
- NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product - November 20, 2007
- NexMed Files NDA for Proprietary Erectile Dysfunction Treatment - September 24, 2007
Company: Agios Pharmaceuticals, Inc.
Treatment for: Acute Myeloid Leukemia
Ivosidenib is an investigational, first-in-class, inhibitor of mutant isocitrate dehydrogenase-1 (IDH1) in development for the treatment of patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an IDH1 mutation.
- FDA Accepts New Drug Application and Grants Priority Review for Ivosidenib in Relapsed or Refractory AML with an IDH1 Mutation - February 15, 2018
- Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Relapsed/Refractory AML and an IDH1 Mutation - December 26, 2017
Jemdel (halobetasol propionate) Lotion
Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis
Jemdel (halobetasol propionate) is a high-potency topical steroid formulation in development for the treatment of plaque psoriasis.
Company: Pfizer Inc.
Treatment for: Non-Small Cell Lung Cancer
Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC).