FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

The US Food and Drug Administration has granted tentative approval for New Drug Applications by US generic drugmaker Mylan (Nasdaq: MYL) for its two dosages of abacavir/lamivudine tablets for oral suspension in the treatment of HIV-1 in pediatric patients.

This is the first abacavir/lamivudine version with scoring to allow for dose adjustment, and is flavored. The approval is carried out through the President's Emergency Plan for AIDS Relief (PEPFAR) program and means the formulations meet all of the agency's quality, safety and efficacy standards.

The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative (CHAI) and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation, at low cost, to a total of 115 resource limited countries including all low-middle  income, least developed countries and sub-Saharan Africa.