Mylan Inc. said that its business Mylan Institutional's Abbreviated New Drug Application (ANDA) for Dexrazoxane for injection, packaged in 250 mg and 500 mg single-use vials has received final approval from the US Food and Drug Administration (FDA).. 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 US sales of approximately $3.4 million for the 12 months ending September 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.