FDA updates labeling for OLANZAPINE FDA Approval Dec. 31, 2025, 13:45 UTC 60 0 comments Labeling changes approved for TORRENT PHARMS LTD. Active ingredient: OLANZAPINE. Decision date: 12/02/2025 Comment Full text
FDA regulatory update for TEVIMBRA FDA Approval Dec. 31, 2025, 13:45 UTC 57 0 comments Administrative update #SUPPL-15 for BEIGENE. Status: Approval. Decision date: 12/02/2025 Comment Full text
FDA updates labeling for RIFADIN FDA Approval Dec. 31, 2025, 13:45 UTC 59 0 comments Labeling changes approved for SANOFI AVENTIS US. Active ingredient: RIFAMPIN. Decision date: 12/05/2025 Comment Full text
FDA grants tentative approval for CARBIDOPA AND LEVODOPA from BIOCON PHARMA LIMITED FDA Approval Dec. 31, 2025, 13:45 UTC 56 0 comments Tentative approval of ANDA #ANDA #220119 for CARBIDOPA,LEVODOPA. Decision date: 12/04/2025 Comment Full text
FDA approves manufacturing change for CEFAZOLIN SODIUM FDA Approval Dec. 31, 2025, 13:45 UTC 44 0 comments Manufacturing process update for HIKMA FARMACEUTICA. Submission: SUPPL-34. Decision date: 12/01/2025 Comment Full text
FDA approves ALBUTEROL SULFATE from AMNEAL IRELAND LTD FDA Approval Dec. 31, 2025, 13:45 UTC 44 0 comments Final approval of ANDA #ANDA #211600 for ALBUTEROL SULFATE. Decision date: 12/01/2025 Comment Full text
FDA approves MACITENTAN from MYLAN FDA Approval Dec. 31, 2025, 13:45 UTC 58 0 comments Final approval of ANDA #ANDA #211161 for MACITENTAN. Decision date: 12/03/2025 Comment Full text
FDA expands indications for JAYPIRCA FDA Approval Dec. 31, 2025, 13:45 UTC 51 0 comments LOXO ONCOL receives approval for new indications. Submission: SUPPL-5. Decision date: 12/02/2025 Comment Full text
FDA approves PROPOFOL from NANJING KING FRIEND FDA Approval Dec. 31, 2025, 13:45 UTC 56 0 comments Final approval of ANDA #ANDA #217945 for PROPOFOL. Decision date: 12/02/2025 Comment Full text
FDA approves MACITENTAN from SEASONS BIOTECH FDA Approval Dec. 31, 2025, 13:45 UTC 53 0 comments Final approval of ANDA #ANDA #211026 for MACITENTAN. Decision date: 12/03/2025 Comment Full text