Mylan : Tentative FDA Approval For Pediatric Formulations Of Abacavir/lamivudine

(RTTNews) - Mylan Inc. (MYL) announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration or FDA for its New Drug Applications or NDAs for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients.

This is the first version of abacavir/lamivudine with scoring to allow for dose adjustment and is also flavored.

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.

Mylan's products are expected to be eligible for purchase in early 2015.

The fixed dose combination of abacavir and lamivudine tablets for oral suspension 60 mg/30 mg and 120 mg/60 mg is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents for pediatric patients.