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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.


Company: Puma Biotechnology, Inc.
Treatment for: Breast Cancer -- Adjuvant

Neratinib is a potent irreversible tyrosine kinase inhibitor in development for the extended adjuvant treatment of HER2-positive early stage breast cancer.

Yuvvexy (estradiol) - formerly TX-004HR

Treatment for: Dyspareunia

Yuvvexy (estradiol) is a topical estrogen in an applicator-free, vaginal, softgel capsule formulation for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.

telotristat etiprate

Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Carcinoid Syndrome

Telotristat etiprate is an oral tryptophan hydroxylase inhibitor in development for the treatment of carcinoid syndrome.


Company: Tesaro, Inc.
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Niraparib is an oral, poly ADP-ribose polymerase (PARP) inhibitor in development for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

Rhopressa (netarsudil) Ophthalmic Solution

Company: Aerie Pharmaceuticals, Inc.
Treatment for: Glaucoma

Rhopressa (netarsudil ophthalmic solution) is a combination Rho Kinase and norepinephrine transporter (ROCK/NET) inhibitor in development for the treatment of glaucoma or ocular hypertension.

IDegLira (insulin degludec and liraglutide) Injection

Company: Novo Nordisk
Treatment for: Diabetes Type 2

IDegLira (insulin degludec and liraglutide) is a once-daily, single injection fixed combination of the basal insulin analogue insulin degludec (Tresiba), and the GLP-1 analogue liraglutide (Victoza), in development for the treatment of adults with type 2 diabetes.


Company: Array BioPharma
Treatment for: NRAS-Mutant Melanoma

Binimetinib is a late-stage small molecule MEK inhibitor in development for the treatment of advanced NRAS-mutant melanoma.

KedRAB (rabies immunoglobulin human)

Company: Kamada Ltd. and Kedrion S.p.A.
Treatment for: Rabies

KedRAB (human rabies immunoglobulin) is a human plasma derived anti-rabies immunoglobulin in development for the post-exposure treatment of rabies.

Ingrezza (valbenazine)

Company: Neurocrine Biosciences, Inc.
Treatment for: Tardive Dyskinesia

Ingrezza (valbenazine) is a novel, highly-selective VMAT2 inhibitor in development for the treatment of tardive dyskinesia.


Company: Ariad Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer

Brigatinib is an investigational anaplastic lymphoma kinase (ALK) inhibitor in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib.

Radicava (edaravone)

Company: Mitsubishi Tanabe Pharma
Treatment for: Amyotrophic Lateral Sclerosis

Radicava (edaravone) is an investigational free radical scavenger that relieves the effects of oxidative stress, a likely factor in the onset and progression of amyotrophic lateral sclerosis.

Parsabiv (etelcalcetide)

Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism

Parsabiv (etelcalcetide) is a novel calcimimetic agent in clinical development for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis.


Company: Clovis Oncology, Inc.
Treatment for: Ovarian Cancer

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed for the treatment of advanced mutant BRCA ovarian cancer.

iGlarLixi (insulin glargine and lixisenatide)

Company: Sanofi
Treatment for: Diabetes Type 2

iGlarLixi (insulin glargine and lixisenatide) is an insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA) fixed-ratio combination in development for the treatment of adults with type 2 diabetes.

AndexXa (andexanet alfa)

Company: Portola Pharmaceuticals, Inc.
Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors

AndexXa (andexanet alfa) is a recombinant protein designed to reverse the anticoagulant effect in patients treated with oral or injectable Factor Xa inhibitors.

SGX942 (dusquetide)

Company: Soligenix, Inc.
Treatment for: Mucositis

SGX942 (dusquetide) is an innate defense regulator (IDR) in development for the treatment of oral mucositis.


Company: Merck & Co., Inc.
Treatment for: Diabetes Type 1, Diabetes Type 2

MK-1293 is an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes.

See also: Generic Approvals, New Drug Approvals, Recent Additions to, Alphabetical Listing of all New Drug Applications, FDA Approval Process

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