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. NRX-100 (ketamine) Company: NRx Pharmaceuticals, Inc.Treatment for: Major Depressive Disorder with Acute Suicidal Ideation NRX-100 (ketamine) is an intravenous formulation of ketamine in development for the treatment of suicidal depression. NRx Pharmaceuticals, Inc. Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression – December 30, 2024 See also: Generic approvals, New drug approvals, Recent additions to Drugs.com, Alphabetical listing of all new drug applications, FDA approval process Avutometinib Company: Verastem