FDA approves DAYBUE STIX from ACADIA PHARMS INC FDA Approval Dec. 31, 2025, 13:45 UTC 58 0 comments Final approval of NDA #NDA #219884 for TROFINETIDE. Decision date: 12/11/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE from SPECGX LLC FDA Approval Dec. 31, 2025, 13:45 UTC 38 0 comments Final approval of ANDA #ANDA #218473 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/10/2025 Comment Full text
FDA approves NUZOLVENCE from ENTASIS THERAP FDA Approval Dec. 31, 2025, 13:45 UTC 60 0 comments Final approval of NDA #NDA #219491 for ZOLIFLODACIN. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for ARIKAYCE KIT FDA Approval Dec. 31, 2025, 13:45 UTC 32 0 comments Labeling changes approved for INSMED INC. Active ingredient: AMIKACIN SULFATE. Decision date: 12/05/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 60 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN SUCCINATE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 58 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN SUCCINATE. Decision date: 12/09/2025 Comment Full text
FDA approves ESTRADIOL from TEVA PHARMS USA INC FDA Approval Dec. 31, 2025, 13:45 UTC 59 0 comments Final approval of ANDA #ANDA #214137 for ESTRADIOL. Decision date: 12/08/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Labeling changes approved for HIBROW HLTHCARE. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/05/2025 Comment Full text
FDA expands indications for RECARBRIO FDA Approval Dec. 31, 2025, 13:45 UTC 62 0 comments MSD MERCK CO receives approval for new indications. Submission: SUPPL-8. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for VECURONIUM BROMIDE FDA Approval Dec. 31, 2025, 13:45 UTC 34 0 comments Labeling changes approved for HIKMA. Active ingredient: VECURONIUM BROMIDE. Decision date: 12/09/2025 Comment Full text