Ranbaxy Laboratories Limited (RLL) had filed an ANDA with the US FDA for zidovudine tablets, 300 mg, last week. This is the first of a series of anti- retroviral (ARV) ANDA filings by RLL that are anticipated in the near term that will be supportive of the US President's Emergency Plan for AIDS Relief (PEPFAR) initiative, a company release stated.

As is customary, RLL will generate and provide appropriate scientific data supporting the efficacy of zidovudine tablets in order to allow the US. FDA to technically review the formulation and grant final approval. With FDA approval, the formulation can then be employed to manage patients afflicted with AIDS in PEPFAR identified countries, when mutually acceptable procurement terms are agreed upon. RLL is committed to supporting PEPFAR by providing anti-retroviral agents that successfully pass regulatory scrutiny, and remain committed and dedicated as well, to supporting the needs of AIDS patients who are candidates for ARV pharmacotherapy.

RLL's plan is to provide single entity products and fixed dose combination products in the future for FDA approval that can then be employed by PEPFAR to meet the clinical needs of patients. As previously announced, RLL has now achieved its goal of making the first filing before the end of the year 2004.

"We are committed to support this humanitarian effort because of the devastating impact that AIDS has had on people's lives throughout the globe. Our contribution is to make affordable ARV products readily available to those patients in need who might not otherwise be able to access therapy," said Dr. Brian Tempest, CEO and managing director of RLL.