FDA updates labeling for ACETAMINOPHEN AND IBUPROFEN FDA Approval Dec. 31, 2025, 13:45 UTC 47 0 comments Labeling changes approved for GRANULES. Active ingredient: ACETAMINOPHEN; IBUPROFEN. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE FDA Approval Dec. 31, 2025, 13:45 UTC 48 0 comments Labeling changes approved for ALEMBIC PHARMS LTD. Active ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA approves NUFYMCO from FORMYCON AG FDA Approval Dec. 31, 2025, 13:45 UTC 47 0 comments Final approval of BLA #BLA #761473 for RANIBIZUMAB-LEYK. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for GABAPENTIN FDA Approval Dec. 31, 2025, 13:45 UTC 40 0 comments Labeling changes approved for SANDOZ. Active ingredient: GABAPENTIN. Decision date: 12/17/2025 Comment Full text
FDA expands indications for RUBRACA FDA Approval Dec. 31, 2025, 13:45 UTC 36 0 comments PHARMAAND receives approval for new indications. Submission: SUPPL-14. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for TIZANIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 48 0 comments Labeling changes approved for APOTEX INC. Active ingredient: TIZANIDINE HYDROCHLORIDE. Decision date: 12/16/2025 Comment Full text
FDA updates labeling for ORILISSA FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for ABBVIE. Active ingredient: ELAGOLIX SODIUM. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for TESTOSTERONE FDA Approval Dec. 31, 2025, 13:45 UTC 44 0 comments Labeling changes approved for ENCUBE. Active ingredient: TESTOSTERONE. Decision date: 12/17/2025 Comment Full text
FDA regulatory update for LEQEMBI FDA Approval Dec. 31, 2025, 13:45 UTC 46 0 comments Administrative update #SUPPL-12 for EISAI INC. Status: Approval. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for FLONASE ALLERGY RELIEF FDA Approval Dec. 31, 2025, 13:45 UTC 42 0 comments Labeling changes approved for HALEON US HOLDINGS. Active ingredient: FLUTICASONE PROPIONATE. Decision date: 12/19/2025 Comment Full text