Monday, December 22, 2008

Tentative Approval of Abacavir Sulfate and Lamivudine Fixed-dose Combination

On December 19, 2008, FDA granted tentative approval for fixed-dose combination scored tablets, made by Aurobindo Pharma Limited' of Hyderabad, India, containing abacavir sulfate and lamivudine, 60mg/30mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection. The tablets are dispersable in water, intended for pediatric patients 3 months - 16 years of age.

The details can be read here.

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