Zydus Worldwide DMCC, a wholly owned subsidiary of Zydus Lifesciences Ltd and Daewoong Pharmaceutical announced that they have entered into an exclusive licensing agreement to co-develop and commercialize Leuprolide Acetate for Depot Suspension in six dosage strengths for the United States (US) market.
Enforcement Report - Week of October 4, 2023
Astellas and Pfizer's Xtandi has been selling for over a decade, and the blockbuster androgen receptor inhibitor is still learning a new trick.
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (“FDA”) for leuprolide acetate for injection.
Amneal's Generic Leuprolide Acetate Receives Approval in the U.S.
Eugia Pharma Generic Leuprolide Acetate Receives Approval in the U.S
DURHAM, N.C., April 4, 2022 /PRNewswire/ -- Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd. focused on development of oncology, immunology, and critical care therapies, announced today, in partnership with Foresee Pharmaceuticals Co., Ltd., the U.S. launch of CAMCEVI™ (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. The U.S. Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021. CAMCEVI™ 42 mg injection is exclusively licensed to Accord BioPharma in the U.S. for commercialization.