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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: 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 metastatic EGFR T790M-mutant non–small cell lung cancer (NSCLC).

SD-809 (deutetrabenazine)

Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Huntington Disease, Tardive Dyskinesia

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


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.

Nuplazid (pimavanserin)

Company: Acadia Pharmaceuticals Inc.
Treatment for: Parkinson’s Disease Psychosis

Nuplazid (pimavanserin) is a selective serotonin inverse agonist (SSIA) in development for the treatment of psychosis associated with Parkinson’s disease.

sofosbuvir and velpatasvir

Company: Gilead Sciences, Inc.
Treatment for: Chronic Hepatitis C

Sofosbuvir/velpatasvir is an investigational nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination in development for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

Zurampic (lesinurad)

Company: AstraZeneca Pharmaceuticals LP
Treatment for: Gout

Lesinurad is a selective uric acid reabsorption inhibitor (SURI) in development for the combination treatment of hyperuricemia associated with gout.

Genvoya (cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide) Tablets

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

Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide or E/C/F/TAF) is an antiretroviral combination for the treatment of HIV infection.


Company: Shire plc
Treatment for: Dry Eye Disease

Lifitegrast is an investigational integrin antagonist for the topical treatment of dry eye disease.

In October 2015, Shire plc announced the U.S. Food and Drug Administration (FDA) had requested an additional clinical study as part of a complete response letter (CRL) to the company’s new drug application for lifitegrast.

dapagliflozin and saxagliptin

Company: AstraZeneca
Treatment for: Diabetes Type 2

Dapagliflozin and saxagliptin is an investigational sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor fixed-dose combination for the treatment of adult patients with type 2 diabetes.

In October 2015, AstraZeneca announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for the dapagliflozin and saxagliptin combination had not been approved.

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.


Company: Jazz Pharmaceuticals plc
Treatment for: Hepatic Veno-Occlusive Disease

Defibrotide is a deoxyribonucleic acid derivative anticoagulant in development for the treatment of severe hepatic veno-occlusive disease (VOD).

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 up to 30 days for the treatment of post-surgical ocular inflammation and pain.

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

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