Apr 4 2012
Mylan Inc. (Nasdaq: MYL) today announced that its Mylan Institutional business has launched Mesna Injection, 100 mg/mL, packaged in 1,000 mg/10mL multiple-dose vials. This product, which has faced recent shortages in the U.S., is the generic version of Baxter Healthcare Corporation's Mesnex Injection® and is indicated as a prophylactic agent in reducing the incidence of ifosfamide-indused hemorrhagic cystitis.
Mesna Injection, 100 mg/mL, had U.S. sales of approximately $11.7 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan has begun shipping its generic version, which has been approved by the U.S. Food and Drug Administration (FDA), presented in 10-vial packs.
Currently, Mylan has 173 ANDAs pending FDA approval representing $100.2 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $26.9 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.