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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.

valbenazine

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

Valbenazine is a novel, highly-selective VMAT2 inhibitor in development for the treatment of tardive dyskinesia.

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.

rucaparib

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.

MK-1293

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.

Arymo ER (morphine sulfate) Extended-Release Tablets

Company: Egalet Corporation
Treatment for: Pain

Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation in development for the management of severe pain.

Xadago (safinamide)

Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease

Xadago (safinamide) is an alpha-aminoamide in development as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease.

Dextenza (dexamethasone) Intracanalicular Depot

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

Dextenza (dexamethasone) is an investigational intracanalicular depot corticosteroid formulation delivering sustained release dexamethasone to the ocular surface for the treatment of post-surgical ocular inflammation and pain.

Vesneo (latanoprostene bunod) Ophthalmic Solution

Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension

Vesneo (latanoprostene bunod ophthalmic solution) is a nitric oxide donating prostaglandin receptor agonist in development for the treatment of patients with open angle glaucoma or ocular hypertension.

neratinib

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.

romosozumab

Company: Amgen Inc.
Treatment for: Osteoporosis

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

Zinplava (bezlotoxumab)

Company: Merck
Treatment for: Clostridial Infection

Zinplava (bezlotoxumab) is a selective, fully-human, monoclonal antibody designed to neutralize Clostridium difficile toxin B and prevent C. difficile infection recurrence.

brodalumab

Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Plaque Psoriasis

Brodalumab is a human anti-interleukin-17-receptor monoclonal antibody in development for the treatment of plaque psoriasis.

SequestOx (naltrexone and oxycodone hydrochloride)

Company: Elite Pharmaceuticals, Inc.
Treatment for: Pain

SequestOx (oxycodone hydrochloride and naltrexone) is an abuse-deterrent opioid formulation in development for the management of moderate to severe pain.

plecanatide

Company: Synergy Pharmaceuticals Inc.
Treatment for: Constipation -- Chronic, Irritable Bowel Syndrome

Plecanatide is a uroguanylin analog in late-stage clinical development for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).

ABP 501 (adalimumab)

Company: Amgen Inc.
Treatment for: Plaque Psoriasis, Rheumatoid Arthritis

ABP 501 (adalimumab) is biosimilar to Humira, an anti-TNF-α monoclonal antibody approved for the treatment of various inflammatory diseases including plaque psoriasis and rheumatoid arthritis.

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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