FDA approves Mylan's generic Prograf Capsules ANDA

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tacrolimus Capsules, 0.5 mg, 1 mg and 5 mg, the generic version of Astellas' Prograf® Capsules, a treatment to prevent rejection in people who have received certain organ transplants.

Tacrolimus Capsules had U.S. sales of approximately $944 million for the 12 months ending June 30, 2010, according to IMS Health. The product will launch immediately.

Currently, Mylan has 137 ANDAs pending FDA approval representing $92 billion in annual brand sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $21 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 according to IMS Health.