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Mylan's Combination Drug Gets Tentative FDA Approval Under PEPFAR

Mylan Inc. (MYL) 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.

by RTTNews Staff Writer

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