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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.

sparsentan

Company: Travere Therapeutics, Inc.
Treatment for: IgA Nephropathy

Sparsentan is a Dual Endothelin Angiotensin Receptor Antagonist (DEARA) in development for the treatment of IgA nephropathy (IgAN).

Furoscix (furosemide)

Company: scPharmaceuticals, Inc.
Treatment for: Heart Failure

Furoscix (furosemide) is a subcutaneous formulation of the approved diuretic furosemide delivered via a wearable, pre-programmed on-body drug delivery system. Furoscix is in development for treatment of congestion in patients with heart failure, and has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.

bimekizumab

Company: UCB, Inc.
Treatment for: Plaque Psoriasis

Bimekizumab is an investigational humanized IgG1 monoclonal antibody in development for the treatment of moderate to severe plaque psoriasis in adults.

lecanemab

Company: Biogen Inc. and Eisai Co., Ltd.
Treatment for: Alzheimer's Disease

Lecanemab is an investigational humanized monoclonal antibody in development for the treatment of Alzheimer’s disease (AD).

surufatinib

Company: Hutchison China MediTech Limited
Treatment for: Neuroendocrine Carcinoma

Surufatinib is a novel, oral angio-immuno kinase inhibitor in development for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (“NET”).

zuranolone

Company: Sage Therapeutics, Inc.
Treatment for: Major Depressive Disorder, Postpartum Depression

Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM) in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

toripalimab

Company: Coherus Biosciences, Inc.
Treatment for: Nasopharyngeal Carcinoma

Toripalimab is an anti-PD-1 monoclonal antibody in development for the treatment of nasopharyngeal carcinoma.

AXS-07 (meloxicam and rizatriptan)

Company: Axsome Therapeutics, Inc.
Treatment for: Migraine

AXS-07 (meloxicam and rizatriptan) is a non-steroidal anti-inflammatory drug and triptan combination in development for the acute treatment of migraine.

daprodustat

Company: GlaxoSmithKline
Treatment for: Anemia Associated with Chronic Renal Failure

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in development for the treatment of patients with anemia of chronic kidney disease (CKD).

pegzilarginase

Company: Aeglea BioTherapeutics, Inc.
Treatment for: Arginase 1 Deficiency

Pegzilarginase is a novel, recombinant human arginase 1 enzyme replacement therapy in development for the treatment of Arginase 1 Deficiency (ARG1-D).

vutrisiran

Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Hereditary Transthyretin-Mediated (hATTR) Amyloidosis

Vutrisiran is an investigational RNAi therapeutic in development for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

omaveloxolone

Company: Reata Pharmaceuticals, Inc.
Treatment for: Friedreich’s Ataxia

Omaveloxolone is an investigational, oral, once-daily, activator of Nrf2 (nuclear factor erythroid 2–related factor 2) in development for the treatment of Friedreich’s ataxia.

Lytenava (bevacizumab-vikg) Intravitreal Injection

Company: Outlook Therapeutics

Lytenava (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab in development for the treatment of wet AMD and other retinal diseases.

futibatinib

Company: Taiho Oncology, Inc.
Treatment for: Cholangiocarcinoma of Biliary Tract

Futibatinib is an investigational, oral, potent, selective, and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies.

vamorolone

Company: Santhera Pharmaceuticals and ReveraGen BioPharma, Inc.
Treatment for: Duchenne Muscular Dystrophy

Vamorolone is a first-in-class steroidal anti-inflammatory in development for the treatment of Duchenne muscular dystrophy (DMD).

Defencath (taurolidine)

Company: CorMedix Inc.
Treatment for: Prevention of Catheter Related Blood Stream Infections (CRBSI)

Defencath (taurolidine) is a synthetic broad-spectrum antimicrobial and antifungal in development for use as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI).

See also: Generic approvals, New drug approvals, Recent additions to Drugs.com, Alphabetical listing of all new drug applications, FDA approval process

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New Drug Applications Archive

2022
January, February, March, April, May
2021
January, February, March, April, May, June, July, August, September, October, November, December
2020
January, February, March, April, May, June, July, August, September, October, November, December
2019
January, February, March, April, May, June, July, August, September, October, November, December
2018
January, February, March, April, May, June, July, August, September, October, November, December
2017
January, February, March, April, May, June, July, August, September, October, November, December
2016
January, February, March, April, May, June, July, August, September, October, November, December
2015
January, February, March, April, May, June, July, August, September, October, November, December
2014
January, February, March, April, May, June, July, August, September, October, November, December
2013
January, February, March, April, May, June, July, August, September, October, November, December
2012
January, February, March, April, May, June, July, August, September, October, November, December
2011
January, February, March, April, May, June, July, August, September, October, November, December
2010
January, February, March, April, May, June, July, August, September, October, November, December
2009
January, February, March, April, May, June, July, August, September, October, November, December
2008
January, February, March, April, May, June, July, August, September, October, November, December
2007
January, February, March, April, May, June, July, August, September, October, November, December
2006
January, February, March, April, May, June, July, August, September, October, November, December
2005
January, February, March, April, May, June, July, August, September, October, November, December
2004
January, February, March, April, May, June, July, August, September, October, November, December

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