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Mylan gains final FDA nod for generic version of Zinecard for Injection.

M2 PHARMA-November 28, 2011-Mylan gains final FDA nod for generic version of Zinecard for Injection(C)2011 M2 COMMUNICATIONS

28 November 2011 - US Mylan Inc (NASDAQ:MYL) said today that its unit Mylan Institutional has obtained final US Food and Drug Administration (FDA) approval 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 chemoprotective agent Zinecard for Injection. Mylan Institutional is shipping this product immediately, the parent company said.

Dexrazoxane for Injection, when indicated for the same use as Zinecard for Injection, had US sales of about USD3.4m (EUR2.5m) for the 12 months to September 2011, according to IMS Health data.

(USD1 = EUR0.749)

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Publication:M2 Pharma
Date:Nov 28, 2011
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