Mylan Inc. reports that its subsidiary Mylan Laboratories Limited has received tentative approval from the US Food and Drug Administration (FDA) for its new drug applications (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 FDA’s tentative approval through the President’s Emergency Plan for AIDS Relief (PEPFAR) program means the formulations meet all of the agency’s quality, safety, and efficacy standards.

The tentative approval follows a 2012 agreement between Mylan, the 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. Abacavir/lamivudine is a fixed-dose combination containing two nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs interfere with the action of the reverse transcriptase enzyme to prevent the virus from replicating. Abacavir/lamivudine was approved in the US in August 2004 under the brand name Epzicom and in Europe in December 2004 under the brand name Kivexa from ViiV Healthcare, the HIV specialty drug company of Pfizer, GlaxoSmithKline, and Shionogi.

Source: Mylan