Acetaminophen Stevens-Johnson Syndrome FDA is evaluating the need for regulatory action. Ajovy (fremanezumab-vfrm) Vyepti (eptinezumab-jjmr) Anaphylactic reaction The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient […]

Actemra (tocilizumab) Hepatitis B reactivation FDA determined that no action is necessary at this time based on available information. Alcohol containing hand sanitizers Blood methanol induced […]

Aimovig (erenumab-aooe) Wrong strength FDA decided that no action is necessary at this time based on available information. Aimovig (erenumab-aooe) Product preparation error The carton labeling, […]

Bridion (sugammadex) injection Arteriospasm coronary (coronary vasospasm) The “Adverse Reactions” section of the labeling was updated in January 2021 to include coronary spasm. Bridion labeling Bydureon […]

CisplatinGeneric products containing cisplatin Aortic thrombosis FDA has determined that the last approved labeling is adequate, and that no further regulatory action is needed at this […]

For Immediate Release: March 04, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, […]

Overview This page provides an overview of human drugs and the requirements that FDA verifies and enforces at the time they are imported or offered for […]

Product: Drugs Recipient: Recipient Name Dr. Krishna Prasad Chigurupati Recipient Title Chairman and Managing Director Granules India Limited Survey No 160/A, 161/E, 162 and 174/A, Gagillapur […]

Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER February 25, 2025 RE: 702106 Dear Sir/Madam: This letter concerns your […]