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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.

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Company: Eisai Co., Ltd.
Treatment for: Thyroid Cancer

Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor in development for the treatment of progressive radioiodine-refractory differentiated thyroid cancer.


Company: Pfizer Inc.
Treatment for: Breast Cancer

Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in development for the combination treatment of ER+, HER2- metastatic breast cancer.


Company: Prosensa Holding N.V.
Treatment for: Duchenne Muscular Dystrophy

Drisapersen is an investigational antisense oligonucleotide in development for the treatment of Duchenne Muscular Dystrophy.


Company: Amgen Inc.
Treatment for: Acute Lymphoblastic Leukemia

Blinatumomab is an investigational bispecific T cell engager (BiTEĀ®) antibody for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Opdivo (nivolumab)

Company: Bristol-Myers Squibb Company
Treatment for: Melanoma - Metastatic

Opdivo (nivolumab) is an investigational PD-1 immune checkpoint inhibitor in development for the treatment of advanced melanoma.


Company: Chimerix, Inc.
Treatment for: Ebola Virus Disease

Brincidofovir is a nucleotide analog broad-spectrum antiviral under FDA review to assess the safety and efficacy in patients with confirmed Ebola virus infection.


Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
Treatment for: Schizophrenia, Depression

Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) in development for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder.

Tuzistra XR

Company: Tris Pharma Inc.
Treatment for: Cold Symptoms

Tuzistra XR is extended-release formulation of an undisclosed existing cough and cold product using OralXR+ extended release formulation technology.

Saxenda (liraglutide)

Company: Novo Nordisk Inc.
Treatment for: Obesity

Saxenda (liraglutide) is a once-daily glucagon-like peptide-1 (GLP-1) analogue in development for the treatment of obesity.

Rapivab (peramivir) Injection

Company: BioCryst Pharmaceuticals, Inc.
Treatment for: Influenza

Rapivab (peramivir) is an intravenously administered anti-viral agent in development for the treatment of influenza, including H7N9 and pandemic H1N1 swine flu viral strains.

Keytruda (pembrolizumab) for Injection

Company: Merck & Co., Inc.
Treatment for: Melanoma - Metastatic

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of metastatic melanoma.


Company: Actavis plc
Treatment for: Irritable Bowel Syndrome

Eluxadoline is a combined mu opioid receptor agonist and delta opioid receptor antagonist in development for the treatment of diarrhea predominant irritable bowel syndrome (IBS-D).


Company: Amgen Inc.
Treatment for: Hyperlipidemia

Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) in development for the treatment for dyslipidemia.


Company: Amgen Inc.

Ivabradine is an investigational If current ("funny" current) inhibitor for the treatment of chronic heart failure.

olodaterol and tiotropium

Company: Boehringer Ingelheim
Treatment for: Chronic Obstructive Pulmonary Disease

Olodaterol and tiotropium is a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) fixed-dose combination in development for the treatment of chronic obstructive pulmonary disease (COPD).

Zalviso (sufentanil) Sublingual Microtablet System

Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain

Zalviso (sufentanil sublingual microtablet system) is a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting.

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

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