FDA updates labeling for MEROPENEM FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for BROOKS STERISCIENCE. Active ingredient: MEROPENEM. Decision date: 12/11/2025 Comment Full text
FDA approves LEROCHOL from LIB THERAPEUTICS, INC. FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Final approval of BLA #BLA #761427 for LERODALCIBEP-LIGA. Decision date: 12/12/2025 Comment Full text
FDA approves LOPINAVIR AND RITONAVIR from MICRO LABS FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Final approval of ANDA #ANDA #214696 for LOPINAVIR; RITONAVIR. Decision date: 12/11/2025 Comment Full text
FDA expands indications for BLUJEPA FDA Approval Dec. 31, 2025, 13:45 UTC 11 0 comments GLAXOSMITHKLINE receives approval for new indications. Submission: SUPPL-1. Decision date: 12/11/2025 Comment Full text
FDA approves NOREPINEPHRINE BITARTRATE from MSN FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Final approval of ANDA #ANDA #218595 for NOREPINEPHRINE BITARTRATE. Decision date: 12/11/2025 Comment Full text
FDA regulatory update for STEQEYMA FDA Approval Dec. 31, 2025, 13:45 UTC 12 0 comments Administrative update #SUPPL-7 for CELLTRION, INC.. Status: Approval. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for XTANDI FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for ASTELLAS. Active ingredient: ENZALUTAMIDE. 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 21 0 comments Labeling changes approved for WATSON LABS. Active ingredient: NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA approves OCTREOTIDE ACETATE from MYLAN LABS LTD FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Final approval of ANDA #ANDA #216589 for OCTREOTIDE ACETATE. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for ALKEM LABS LTD. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/12/2025 Comment Full text