Mylan gets approval for pediatric HIV/AIDS therapy

Heather Bresch, CEO, Mylan.

PITTSBURGH, US: Mylan Inc announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Ltd) has received tentative approval from US Food and Drug Administration under the President’s Emergency Plan for AIDS Relief (PEPFAR) for its new drug application (NDA) for Abacavir Sulfate and Lamivudine tablets, 60 mg/30 mg. This fixed-dose combination product was developed for use in treating children with HIV/AIDS and is based on the adult-strength.

Abacavir Sulfate and Lamivudine Tablets are used in combination with other medications to control HIV infection. Mylan also has received approval for this pediatric FDC therapy from the World Health Organization under their prequalification of medicines programme. The product will be eligible for purchase outside US in certain developing countries. “The approval of Abacavir Sulfate and Lamivudine further supports Mylan’s mission to continue expanding access to high quality medicine around the world, which is especially crucial for children living with HIV/AIDS. This product combines two medications in one tablet, which may support treatment adherence in children as it reduces the pill burden often associated with complex antiretroviral regimens,” said Heather Bresch, CEO, Mylan.

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