Generic Drug for HIV/AIDS Gains FDA's Tentative Approval

February 3, 2005
Pharmaceutical Technology

Generic Drug for HIV/AIDS Gains FDA's Tentative Approval

Forthe first time, the US Food and Drug Administration has grantedtentative approval of an HIV drug regimen manufactured by a generic pharmaceutical company based outside the US. Developed by Aspen Pharmacare (Durban,South Africa,,the antiretroviral regimenconsists of copackaged lamivudine–zidovudine fixed-dose combinationtablets and nevirapine tablets.

Lamivudine–zidovudine fixed-dose combination tablets are generics ofthe already-approved "Combivir" tablets (GlaxoSmithKline,,and the nevirapine tablets are a generic version of "Viramune" tablets(Boehringer-Ingelheim,

"Tentative approval" status means that although the product meets FDA'sstandards of quality, safety, and efficacy for marketing in the UnitedStates, existing patents and/or exclusivity prevent it from USmarketing. The action also makes Aspen's product available forpotential procurement by President Bush's Emergency Plan for AIDSRelief, a program first announced in 2003 that provides $15 billion tocombat HIV/AIDS over five years, especially in countries hardest hit bythe disease. The plan also facilitates FDA's expedited review processfor making safe, high-quality products available to patients withHIV/AIDS. After Aspen submitted its marketing application on 13 January2005, FDA completed its review within two weeks.

The first approval in the United States of a generic antiretroviralproduct to treat HIV/AIDS was granted in December 2004 to BarrLaboratories (,which manufactures a genericformulation of "Didanosine" delayed-release capsules (Bristol MyersSquibb,

–Maribel Rios