Triple HIV combo for children approved under PEPFAR

Executive Summary

The first triple-combination drug for treating HIV-infected children under the age of 12 years receives tentative approval from FDA Aug. 13 as part of the President's Emergency Plan for AIDS Relief. Approved as a 505 (b)(2) NDA, the twice-daily dissolvable tablet from Cipla combines lamivudine (GlaxoSmithKline's Epivir), stavudine (Bristol-Myers Squibb's Zerit) and nevirapine (Boehringer Ingelheim's Viramune). The tablet formulation makes the drug suitable for use in regions with high temperatures and high humidity and enables treatment of children weighing as little as 5 kg, Division of Antiviral Products Director Debra Birnkrant notes. FDA also gives tentative approval under PEPFAR for nevirapine tablets to be used with antiretrovirals for treating HIV-1...