Enforcement Report - Week of April 3, 2024
Enforcement Report - Week of January 24, 2024
Enforcement Report - Week of November 15, 2023
Par Sterile's Generic Doxycycline Hyclate Receives Approval in the U.S.
Par Sterile Products Generic Naloxone Hydrochloride Receives Approval Approval in the U.S.
Par Sterile Products Generic Posaconazole Receives Approval in the U.S.
Endo International plc announced that its Par Sterile Products business has begun shipping Vasostrict, vasopressin injection, USP, in ready-to-use 100 mL pre-mix bottles. It's the first and only ready-to-use formulation of the drug.
Par Sterile's Generic Methylprednisolone Acetate Receives Approval in the U.S.
The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
DUBLIN, Nov. 17, 2021 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (Endo) today announced that its subsidiary, Par Sterile Products, LLC (Par Sterile), has entered into a cooperative agreement to expand its sterile fill-finish manufacturing production capacity and capabilities at its Rochester, Michigan plant to support the U.S. government's national defense efforts regarding production of critical medicines advancing pandemic preparation.