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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.

Empliciti (elotuzumab)

Company: Bristol-Myers Squibb Company and AbbVie
Treatment for: Multiple Myeloma

Empliciti (elotuzumab) is an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody in development for the combination treatment of multiple myeloma in patients who have received one or more prior therapies.

LPCN 1021 (testosterone)

Company: Lipocine Inc.
Treatment for: Hypogonadism -- Male

LPCN 1021 is an oral testosterone product in development for the treatment of hypogonadism.

obeticholic acid

Company: Intercept Pharmaceuticals, Inc.
Treatment for: Biliary Cirrhosis

Obeticholic acid is a first-in-class farnesoid X receptor (FXR) agonist in development for the treatment of primary biliary cirrhosis.

etelcalcetide

Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism

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.

Aristada (aripiprazole lauroxil) Injection

Company: Alkermes plc
Treatment for: Schizophrenia

Aristada (aripiprazole lauroxil) is an injectable atypical antipsychotic with one-month and extended-duration formulations in development for the treatment of schizophrenia.

BromSite (bromfenac) Ophthalmic Solution

Company: InSite Vision Incorporated
Treatment for: Postoperative Ocular Inflammation

BromSite (bromfenac) is a low dose nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution in development for the treatment of inflammation and prevention of pain in cataract surgery.

SD-809 (deutetrabenazine)

Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Huntington Disease

SD-809 (deutetrabenazine) is a vesicular monoamine 2 transporter (VMAT2) inhibitor in development for the treatment of chorea associated with Huntington disease.

Xtampza ER (oxycodone) Extended-Release Capsules

Company: Collegium Pharmaceutical, Inc.
Treatment for: Chronic Pain

Xtampza ER (oxycodone) is an extended-release, abuse-deterrent narcotic analgesic in development for the treatment of chronic pain.

deflazacort

Company: Marathon Pharmaceuticals, LLC
Treatment for: Duchenne Muscular Dystrophy

Deflazacort is a glucocorticoid in development for the treatment of Duchenne Muscular Dystrophy.

rociletinib

Company: Clovis Oncology, Inc.
Treatment for: Non-Small Cell Lung Cancer

Rociletinib is a mutant-selective inhibitor of epidermal growth factor receptor (EGFR) in development for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC).

Narcan (naloxone) Nasal Spray

Company: Lightlake Therapeutics Inc.
Treatment for: Opioid Overdose

Narcan (naloxone) nasal spray is an intranasal opioid antagonist formulation in development for the treatment of opioid overdose.

ZS-9 (sodium zirconium cyclosilicate)

Company: ZS Pharma, Inc.
Treatment for: Hyperkalemia

ZS-9 (sodium zirconium cyclosilicate) is a crystalline lattice potassium ion-trap in development for the treatment of hyperkalemia.

elbasvir and grazoprevir

Company: Merck & Co., Inc.
Treatment for: Chronic Hepatitis C

Elbasvir and grazoprevir is an investigational, once-daily single tablet NS5A replication complex inhibitor and NS3/4A protease inhibitor combination in development for the treatment of multiple HCV genotypes.

Rayaldee (calcifediol)

Company: OPKO Health, Inc.
Treatment for: Secondary Hyperparathyroidism

Rayaldee (calcifediol modified-release) is a first-in-class oral vitamin D prohormone treatment in development for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

ixazomib

Company: Takeda Pharmaceutical Company Limited
Treatment for: Multiple Myeloma

Ixazomib is an investigational oral proteasome inhibitor in development for the treatment of patients with relapsed and/or refractory multiple myeloma.

entrectinib

Company: Ignyta, Inc.
Treatment for: Neuroblastoma

Entrectinib is a potent, novel, orally available, selective tyrosine kinase inhibitor in development for the treatment of neuroblastoma.

emtricitabine, rilpivirine and tenofovir alafenamide

Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Emtricitabine/rilpivirine/tenofovir alafenamide is an investigational nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination in development for the treatment of HIV-1 infection.

cobimetinib

Company: Genentech
Treatment for: Melanoma - Metastatic

Cobimetinib is an investigational MEK inhibitor in development for the combination treatment of advanced melanoma.

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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