FDA Approves Epivir, Ziagen Labeling Updates
The Food and Drug Administration (FDA) has approved labeling revisions for Epivir (lamivudine; GlaxoSmithKline) and Ziagen (abacavir sulfate; ViiV Healthcare) to provide for once-daily dosing in patients ≥3 months old in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The updated Epivir and Ziagen labeling now include a table for weight-based dosing recommendations, as well as safety data from the COL105677 trial that compared once-daily and twice-daily dosing in pediatric patients. Pharmacokinetic data and study results for once-daily dosing in pediatric patients have been included in the Clinical Pharmacology and Clinical Studies sections accordingly.
Epivir and Ziagen are both nucleoside analogues (reverse transcriptase inhibitors) indicated for the treatment of HIV-1 infection.
For more information visit FDA.gov.