Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) […]

On This Page Date: December 11, 2025 Time: 9:00 a.m. – 10:30 a.m. ET Register Here Visit CDER Small Business and Industry Assistance (SBIA) Homepage About […]

Product: Drugs Recipient: Recipient Name Mr. Sandeep Kumar Recipient Title Vice President – Quality Natco Pharma Limited Pharma Division, Kothur VillageRangareddy 509228TelanganaIndia Issuing Office: Center for […]

Docket Number: FDA-2025-D-3023 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]

MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers.   Report a Problem   Safety Information   Stay Informed MedWatch receives reports from the public and […]

Action The U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) tablets to treat adults with acromegaly who have had an inadequate response to surgery and/or for […]