Mylan Inc. (MYL: Quote) said its subsidiary Mylan Laboratories Limited received tentative approval from FDA for its New Drug Application for Abacavir Sulfate and Lamivudine Tablets, 60 mg/30 mg. This fixed-dose combination is intended to treating children with HIV/AIDS. The approval is under the President's Emergency Plan for AIDS Relief or PEPFAR.
The combination is based on the adult-strength, brand version of the product Epzicom, by Viiv Healthcare.
Mylan also has received approval for this pediatric FDC therapy from the World Health Organization under their Prequalification of Medicines Programme.
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by RTT Staff Writer
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