FDA approves Mylan's generic Dexrazoxane for Injection ANDA

Mylan Inc. (Nasdaq: MYL) today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dexrazoxane for Injection, packaged in 250 mg and 500 mg Single-use Vials. This product is the generic version of Pharmacia & Upjohn's Zinecard^® for Injection, a chemoprotective agent.

Dexrazoxane for Injection, when indicated for the same use as Zinecard for Injection, had U.S. sales of approximately $3.4 million for the 12 months ending Sept. 30, 2011, according to IMS Health. Mylan Institutional is shipping this product immediately.   

Currently, Mylan has 161 ANDAs pending FDA approval representing $97.7 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $26.9 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.