Mylan gets tentative FDA approval for generic Epzicom

US generics major Mylan (Nasdaq: MYL) says that its subsidiary Mylan Laboratories has received tentative approval from the US Food and Drug Administration under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for a combination of abacavir sulfate and lamivudine tablets, 60mg/30mg.

This fixed-dose combination product was developed for use in treating children with HIV/AIDS and is based on the adult-strength, brand version of the product Epzicom from Viiv Healthcare, the AIDS joint venture of GlaxoSmithKline and Pfizer established in 2009. Mylan received tentative PEPFAR approval for its adult-strength, generic version of Epzicom in March 2009.

Mylan chief executive Heather Bresch said: "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."