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FDA tentatively approves abacavir combination tablet for children

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The FDA has granted tentative approval for a fixed-dose combination tablet containing 60 mg abacavir sulfate and 30 mg lamivudine for the treatment of HIV in children aged 3 months and older.

Children eligible for treatment with this formulation must weigh at least 5 kg.

The application for the tablet — which is manufactured by Cipla Limited — was reviewed under expedited provisions in the US President’s Emergency Plan for AIDS Relief (PEPFAR).

Under the provisions of the tentative approval, the drug is eligible for purchase as part of the PEPFAR program, but it may not be marketed in the US because of existing patent rights. The formulation has met quality, safety and efficacy standards in the US.

For more information, visit the FDA website.

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