FDA approves WEGOVY from NOVO NORDISK INC FDA Approval Dec. 31, 2025, 13:45 UTC 13 0 comments Final approval of NDA #NDA #218316 for SEMAGLUTIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 11 0 comments Labeling changes approved for SOMERSET THERAPS LLC. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for METHADOSE FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE AND IBUPROFEN FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments Labeling changes approved for ACTAVIS ELIZABETH. Active ingredient: IBUPROFEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA regulatory update for HUMIRA FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Administrative update #SUPPL-425 for ABBVIE INC. Status: Approval. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Labeling changes approved for MYLAN. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Labeling changes approved for CHARTWELL. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for YONDELIS FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments Labeling changes approved for JANSSEN PRODS. Active ingredient: TRABECTEDIN. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for QDOLO FDA Approval Dec. 31, 2025, 13:45 UTC 11 0 comments Labeling changes approved for ATHENA. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 13 0 comments Labeling changes approved for HIKMA. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text