Mylan Inc. (NASDAQ:MYL), a generic and specialty pharmaceutical company, said its subsidiary received tentative Food and Drug Administration approval for pediatric HIV/AIDS therapy under the President's Emergency Plan for AIDS Relief (PEPFAR).
Mylan Laboratories Ltd. received tentative approval for its new drug application (NDA) for Abacavir Sulfate and Lamivudine Tablets, 60 mg/30 mg.
The tablets, which was developed for use in treating children with HIV/AIDS, is a fixed-dose combination (FDC) product. It is based on the adult-strength, brand version of the product EPZICOM, by Viiv Healthcare.
The 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. Mylan received tentative PEPFAR approval for its adult-strength, generic version of EPZICOM on Mar. 30, 2009.
In order to control HIV infection, Abacavir Sulfate and Lamivudine Tablets are used in combination with other medications. The FDA's tentative approval under PEPFAR means that Mylan's product meets all of the agency's manufacturing quality, safety and efficacy standards.
Mylan also has got approval for this pediatric FDC therapy from the World Health Organization (WHO) under their Prequalification of Medicines Programme.
The product will be eligible for purchase outside the U.S. in certain developing countries, where about one-third of HIV/AIDS patients depend on a Mylan ARV product.
MYL closed Wednesday's regular session at $23.44. Over the past 52 weeks, the stock has been trading between $15.49 and $25.46.