Mylan Inc awarded FDA approval for generic chemoprotective agent Zinecard for Injection.
M2 EQUITYBITES-November 29, 2011-Mylan Inc awarded FDA approval for generic chemoprotective agent Zinecard for Injection(C)2011 M2 COMMUNICATIONS http://www.m2.com
Pharmaceutical company Mylan Inc (Nasdaq:MYL) reported on Monday the receipt of final approval from the US 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 approval was awarded to the company's business, Mylan Institutional.
The company added Dexrazoxane for Injection is the generic version of Pharmacia & Upjohn's Zinecard for Injection, which is a chemoprotective agent. The generic product is being shipped with immediate effect.
According to IMS Health, Dexrazoxane for Injection, when indicated for the same use as Zinecard for Injection, had US sales of about USD3.4m for the 12 months ending 30 September 2011.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Nov 29, 2011|
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