CANONSBURG (dpa-AFX) - Mylan Inc. (MYL) announced Wednesday that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration or FDA for its Abbreviated New Drug Application or ANDA for Nevirapine Tablets USP, 200 mg.
The company said that the product is the generic version of Boehringer Ingelheim's Viramune and is indicated for combination antiretroviral or ARV treatment of HIV-1 infection.
Mylan CEO Heather Bresch said, 'The launch of Nevirapine Tablets, 200 mg, in the U.S. further expands the reach of Mylan's global ARV portfolio.'
Nevirapine Tablets, 200 mg, had U.S. sales of approximately $116.6 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan is shipping its product immediately.
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© 2012 AFX News
