FDA approve additional Indian generics

In the last issue of HTB we reported that six Indian manufactured generic ARVs received FDA tentative approval.

Further approvals have since been granted for a generic combination drug product consisting of lamivudine and zidovudine, manufactured by Aurobindo Pharma (on 7 July 2005); and zidovudine tablets manufactured by Ranbaxy Laboratories (on 13 July).

Tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, it meets the quality, safety and efficacy standards for U.S. marketing. This makes these generic products eligible for purchase and use outside the United States under the Presidents Emergency Plan for AIDS Relief (PEPFAR).

When this fast-track approval for generic antiretroviral drugs was first announced there was wide skepticism that may have been a stalling mechanism in order to retain preferential purchase but the US government for US-manufactured brand ARV. While FDA approval shouldnt be necessary in addition to the WHO pre-qualification process, this rapid series of tentative approvals should at least end earlier attempts by some organisations to discredit the quality of the generic ARVs produced by the largest major Indian generic companies.

An archive of past list serve announcements is available on the FDA web site at:
http://www.fda.gov/