FDA approves VYBRIQUE from IBSA INST BIO FDA Approval Dec. 17, 2025, 19:40 UTC 30 0 comments Final approval of NDA #NDA #210858 for SILDENAFIL. Decision date: 12/16/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE from ASCENT PHARMS INC FDA Approval Dec. 17, 2025, 09:52 UTC 40 0 comments Final approval of ANDA #ANDA #219727 for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE FDA Approval Dec. 16, 2025, 09:39 UTC 45 0 comments Labeling changes approved for PHARMOBEDIENT. Active ingredient: CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA approves DEFLAZACORT from AMNEAL FDA Approval Dec. 16, 2025, 05:06 UTC 44 0 comments Final approval of ANDA #ANDA #217173 for DEFLAZACORT. Decision date: 12/12/2025 Comment Full text
FDA approves LOPINAVIR AND RITONAVIR from MICRO LABS FDA Approval Dec. 16, 2025, 05:06 UTC 44 0 comments Final approval of ANDA #ANDA #214696 for LOPINAVIR; RITONAVIR. Decision date: 12/11/2025 Comment Full text
FDA approves TERIPARATIDE from AMPHASTAR PHARMS INC FDA Approval Dec. 16, 2025, 05:06 UTC 38 0 comments Final approval of ANDA #ANDA #213641 for TERIPARATIDE. Decision date: 12/12/2025 Comment Full text
FDA approves OCTREOTIDE ACETATE from MYLAN LABS LTD FDA Approval Dec. 16, 2025, 05:06 UTC 38 0 comments Final approval of ANDA #ANDA #216589 for OCTREOTIDE ACETATE. Decision date: 12/12/2025 Comment Full text
FDA approves CARDAMYST from Milestone Pharmaceuticals USA, Inc. FDA Approval Dec. 15, 2025, 19:03 UTC 38 0 comments Final approval of NDA #NDA #218571 for ETRIPAMIL. Decision date: 12/12/2025 Comment Full text
FDA approves NUZOLVENCE from ENTASIS THERAP FDA Approval Dec. 15, 2025, 18:57 UTC 34 0 comments Final approval of NDA #NDA #219491 for ZOLIFLODACIN. Decision date: 12/12/2025 Comment Full text
FDA approves LEROCHOL from LIB THERAPEUTICS, INC. FDA Approval Dec. 15, 2025, 18:57 UTC 35 0 comments Final approval of BLA #BLA #761427 for LERODALCIBEP-LIGA. Decision date: 12/12/2025 Comment Full text