FDA approves generic AZT/3TC/NVP fixed dose combination

29 March 2005. Related: Treatment access.

The Food and Drug Administration (FDA) announced on 25 January the tentative approval of a copackaged antiretroviral drug regimen, consisting of fixed dose combination of AZT/3TC/nevirapine tablets for the treatment of HIV-1 infection in adults. It is manufactured by Aspen Pharmacare of South Africa.

A Tentative Approval means that FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, even though it may not yet be marketed in the U.S. due to existing patents and/or exclusivity.

The co-packaged drug products will therfore be available for potential procurement by PEPFAR for use in South Africa and developing nations. It is the first tentative approval under the new expedited FDA review process.

Source: FDA press release