Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has receivedapproval from the FDA for its AbbreviatedNew Drug Application (ANDA) for Bicalutamide Tablets, 50 mg.Bicalutamide Tablets are the generic version of AstraZeneca’s prostatecancer treatment Casodex(R), which had total U.S. sales of approximately $322million for the 12 months ending March 31 for the same strength, according toIMS Health. Mylan has begun to ship this product. Currently, Mylan has 118 ANDAs pending FDA approval representing $82.8billion in annual brand sales, according to IMS Health. Thirty-five of thesepending ANDAs are potential first-to-file opportunities, representing $16.7billion in annual brand sales, according to IMS Health.
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