FDA updates labeling for XTANDI FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Labeling changes approved for ASTELLAS. Active ingredient: ENZALUTAMIDE. Decision date: 12/11/2025 Comment Full text
FDA updates labeling for ROMVIMZA FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for DECIPHERA PHARMS. Active ingredient: VIMSELTINIB. Decision date: 12/12/2025 Comment Full text
FDA grants tentative approval for MIRABEGRON from SUNSHINE LAKE PHARMA CO LTD FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Tentative approval of ANDA #ANDA #216757 for MIRABEGRON. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for ALKEM LABS LTD. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/12/2025 Comment Full text
FDA approves ORLADEYO from BIOCRYST FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Final approval of NDA #NDA #219776 for BEROTRALSTAT DIHYDROCHLORIDE. Decision date: 12/11/2025 Comment Full text
FDA updates labeling for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Labeling changes approved for WATSON LABS. Active ingredient: NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA approves manufacturing change for NISOLDIPINE FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments Manufacturing process update for AMTA. Submission: SUPPL-2. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Labeling changes approved for SUN PHARM. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for DEPO-PROVERA FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for PFIZER. Active ingredient: MEDROXYPROGESTERONE ACETATE. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for DEPO-SUBQ PROVERA 104 FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Labeling changes approved for PFIZER. Active ingredient: MEDROXYPROGESTERONE ACETATE. Decision date: 12/12/2025 Comment Full text