Mylan Expands Gastroenterology Portfolio With Generic for Prevacid Tablets
Mylan, Fujifilm Kyowa Kirin Biologics Receive Marketing Authorization for Biosimilar to Humira
Mylan and Fujifilm Kyowa Kirin Biologics Co. today announced that the European Commission (EC) has granted marketing authorization for Hulio, a biosimilar to AbbVie’s Humira (adalimumab), for all indications. The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the development program including analytical, functional,…
Mylan Launches Generic Version Of The Novartis Exelon Patch
Mylan N.V. today announced the U.S. launch of Rivastigmine Transdermal System, 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs, a generic version of Novartis’ Exelon Patch. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment…
Teva Dismisses Litigation After Mylan Wins US Court Ruling
Mylan N.V. announced that Teva has dismissed its pending district court litigation regarding Mylan’s Glatiramer Acetate Injection 40 mg/mL, the first generic version of Copaxone 40 mg/mL. The litigation involved two non-Orange Book listed patents, U.S. Patent Nos. 9,155,775 and 9,763,993, relating to the final sterile filtration step in the manufacturing process for glatiramer acetate products. Teva dropped litigation on the patents after…
Mylan Launches Generic Clolar For Injection
Mylan N.V. today announced the U.S. launch of Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Dose Vials, a generic version of Genzyme’s Clolar. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for the product, which is indicated for the treatment of pediatric patients 1 to…
Mylan 3Q Revenue Off Partly Due To EpiPen Generic
Mylan Launches Generic Cancidas for Injection
Mylan $465M Settlement with DOJ Over EpiPen Medicaid Issue Finalized
Mylan finalizes settlement agreement on Medicaid rebate classification for EpiPen Auto-Injector. Mylan N.V. announced that its subsidiaries, Mylan Inc. and Mylan Specialty L.P., have signed an agreement with the U.S. Department of Justice (DOJ) and two relators finalizing the Medicaid drug rebate settlement that the company announced on Oct. 7, 2016 for $465 million. The settlement resolves claims relating…
