Ranbaxy Adds to HIV Filings at WHO, U.S. FDA
Ranbaxy Laboratories has ramped up its filings of HIV antiretroviral (ARV) agents at the World Health Organisation (WHO) and with U.S. regulators as part of its commitment to provide these medicines in countries where they are urgently needed, according to the company.
The Indian firm submitted two additional filings to the WHO for its approval, and made one more filing with the U.S. FDA.
The WHO filings take the number of Ranbaxy ARVs submitted to the authority to five, while the FDA filing, which has been submitted under the expedited review process for the president's emergency programme for AIDS relief (PEPFAR), takes the total number of ARV filings with the U.S. agency to four, according to the company.
Speaking on the development, Brian Tempest, CEO and managing director of Ranbaxy
Laboratories, said, "Ranbaxy remains committed toward refiling its ARVs
with the WHO and the U.S. FDA, under the PEPFAR Program. By this summer, we
expect most of our range of HIV medicines to be filed with WHO and U.S. FDA.
This is yet another step in making these quality medicines available widely
in countries that urgently need them."