FDA expands indications for ADDYI FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments SPROUT PHARMS receives approval for new indications. Submission: SUPPL-13. Decision date: 12/13/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Labeling changes approved for TEVA. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/11/2025 Comment Full text
FDA approves OCTREOTIDE ACETATE from MYLAN LABS LTD FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Final approval of ANDA #ANDA #216589 for OCTREOTIDE ACETATE. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for MEROPENEM FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Labeling changes approved for BROOKS STERISCIENCE. Active ingredient: MEROPENEM. Decision date: 12/11/2025 Comment Full text
FDA approves ISOPROTERENOL HYDROCHLORIDE from DEVA HOLDING AS FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Final approval of ANDA #ANDA #213305 for ISOPROTERENOL HYDROCHLORIDE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for REZZAYO FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Labeling changes approved for MUNDIPHARMA. Active ingredient: REZAFUNGIN ACETATE. Decision date: 12/10/2025 Comment Full text
FDA approves TERIPARATIDE from AMPHASTAR PHARMS INC FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Final approval of ANDA #ANDA #213641 for TERIPARATIDE. Decision date: 12/12/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE from AUROBINDO PHARMA LIMITED FDA Approval Dec. 31, 2025, 13:45 UTC 34 0 comments Tentative approval of ANDA #ANDA #211489 for DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE. Decision date: 12/10/2025 Comment Full text
FDA expands indications for AKEEGA FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments JANSSEN BIOTECH receives approval for new indications. Submission: SUPPL-1. Decision date: 12/12/2025 Comment Full text
FDA approves LEROCHOL from LIB THERAPEUTICS, INC. FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Final approval of BLA #BLA #761427 for LERODALCIBEP-LIGA. Decision date: 12/12/2025 Comment Full text