Epzicom Approved for Pediatric Use
The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epzicom (abacavir sulfate and lamivudine; GlaxoSmithKline) for once-daily dosing in pediatric patients weighing ≥25kg. Epzicom was initially approved for use in patients aged ≥18 years.
The FDA waived the pediatric study requirement of the Pediatric Research Equity Act (PREA) for patients <6 years of age or weighing <25kg because this combination does not provide a meaningful benefit over existing therapies. Thus, development of an age appropriate formulation for patients weighing <25kg is not necessary.
Epzicom contains abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, and is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients weighing at least 25kg. It is supplied as 600mg/300mg tablets in 30-count bottles.
For more information call (888) 463-6332 or visit FDA.gov.