FDA tentatively approves generic AIDS drug
The FDA granted tentative approval to the generic drug lamivudine for pediatric patients with HIV.
As such, lamivudine will be available for purchase outside the U.S. under President Bush's Emergency Plan for AIDS Relief, a $15-billion plan to provide treatment and palliative care to patients with HIV/AIDS over five years and prevent new cases among 15 of the hardest hit countries.
The drug will be manufactured by Hyderabad, India concern Aurobindo Pharma LTD.
The FDA action marks the first generic version of Epivir Oral Solution, manufactured by GlaxoSmithKline. If the generic were to gain full approval, it would become the second non-branded AIDS treatment.
Another generic antiretroviral drug product, didanosine from Barr Laboratories, has full approval for U.S marketing.
The agency said its tentative approval means that, although existing patents and/or exclusivity prevent U.S. marketing of the drug, lamivudine meets FDA safety, efficacy, and manufacturing quality standards required for sales in the U.S.