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Msg  48 of 58  at  12/1/2011 2:57:01 PM  by

mlkrborn


FDA approval? $20

Mylan Labs receives tentative FDA approval through PEPFAR for first heat-stable, fixed-dose combination of atazanavir sulfate and ritonavir tablets for HIV/AIDS (MYL) 19.79 +0.26 : Co announced that its subsidiary Mylan Laboratories has received tentative approval from the FDA through the President's Emergency Plan for AIDS Relief for its New Drug Application for Atazanavir Sulfate and Ritonavir Tablets, 300 mg/100 mg. The FDA's tentative approval through PEPFAR signifies that Mylan's product meets all of the agency's manufacturing quality, safety and efficacy standards. Atazanavir and Ritonavir are the generic versions of Bristol-Myers Squibb's Reyataz and Abbott Labs (ABT) Norvir, respectively.


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