Salix Announces a Phase 2 Investigator-Initiated Study of RELISTOR(R)
Gland's Generic Methylnaltrexone Bromide Receives Receives Approval in the U.S.
Wilmington, DE – November 01, 2022 – Noramco, LLC, a leading North American producer of controlled substance and specialty bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has reactivated its previously filed Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for the active pharmaceutical ingredient methylnaltrexone bromide. The DMF number is 026528 and the FDA has acknowledged the DMF is again active.
Aegerion's Biologic Myalept (Metreleptin) Receives Approval in the U.S.
Bausch Health Companies and Progenics Pharmaceuticals announced today that the US District Court of New Jersey upheld the validity and determined Actavis' infringement of a patent protecting Relistor (methylnaltrexone bromide) tablets, expiring March 2031.