News
29 Nov 2011
Mylan Receives Approval for Dexrazoxane for Injection
Mylan has received final approval from the FDA for its Abbreviated New Drug Application for Dexrazoxane for Injection.
Mylan Inc. announced Monday that its business Mylan Institutional has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Dexrazoxane for Injection, packaged in 250 mg and 500 mg Single-use Vials.
The 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.
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