Ranbaxy files three generic ARVs with US FDA
Ranbaxy Laboratories Limited (Ranbaxy) announced on 10 January that the Company has so far made three filings of its Anti-Retrovirals (ARVs), to the USFDA for its approval under the expedited review process of the US Presidents Emergency Plan for AIDS Relief (PEPFAR).
Earlier, in July 2004, Ranbaxy had said that the Company would make its first ARV filing with the US FDA under the PEPFAR, by the end of 2004. Ranbaxy has met this expectation and has to date filed three ARVs with the USFDA after the first ARV filing in October 2004.
The Company will be filing its complete range of ARVs including Fixed Dose Combinations, with the both the US FDA and for WHO prequalification, and expects to complete a majority of the filings to the USFDA and to the WHO by March 2005.
Source: Ranbaxy press release online at