Tentative Approval Granted for Pediatric HIV-1 Combo Drug
Mylan announced it has received tentative approval from the Food and Drug Administration (FDA) for Abacavir/Lamivudine Tablets for Oral Suspension for the treatment of pediatric HIV-1 infection in combination with other antiretroviral drugs. This is the first formulation that is flavored and is scored to allow for dose adjustments.
The drug combines two nucleoside reverse transcriptase inhibitors (NRTIs). Abacavir inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA. Lamivudine inhibits RT by DNA chain termination after incorporation of the nucleotide analogue. Abacavir/Lamivudine is currently marketed as Epzicom tablets (GlaxoSmithKline).
Abacavir/Lamivudine Tablets for Oral Suspension were tentatively approved through the President's Emergency Plan for AIDS Relief (PEPFAR) program. They will be available in 60mg/30mg and 120mg/60mg strengths in early 2015.
For more information call (800) RX-MYLAN or visit Mylan.com.