FDA tentatively approves Aurobindo's combined HIV regimen

The US Food and Drug Administration says it has given "tentative approval" to the co-packaging of three antiretrovirals as an initial therapy for HIV/AIDS. The regimen, which is manufactured by Indian drugmaker Aurobindo Pharma, combines lamivudine/zidovudine fixed dose tablets with efavirenz and is intended for the treatment of HIV-1 in infected adults.

Murray Lumpkin, the FDA's deputy commissioner for international and special programs, said that the co-packaging of the regimen should make it easier to distribute and more straightforward for patients to use. The tentative approval indicates that, despite the inability to approve the drug in the USA due to existing patents and exclusivity deals, the product has met all the agency's manufacturing quality and clinical safety standards.

The product is also eligible for consideration under the US President's Emergency Plan for AIDS Relief (PEPFAR), which provides money to fight HIV/AIDS that was established in 2003.