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.

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Epivir and Ziagen are both nucleoside analogues (reverse transcriptase inhibitors) indicated for the treatment of HIV-1 infection.

For more information visit FDA.gov.