Mylan Receives FDA Approval For Bicalutamide

Mylan has announced that its subsidiary Mylan has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Bicalutamide Tablets, 50mg.

Bicalutamide Tablets are the generic version of AstraZeneca’s prostate cancer treatment Casodex. Mylan has begun to ship this product.

Currently, Mylan has 118 ANDAs pending FDA approval representing $82.8 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $16.7 billion in annual brand sales, according to IMS Health.

Mylan, a generics and specialty pharmaceutical company, which maintains a broad product portfolio supported by a product pipeline. The company is focused on respiratory and allergy therapies.