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news.Ranbaxy Laboratories Limited has made two additional filings of its HIV anti-retroviral agents with the World Health Organization for its approval, and one more filing with the FDA.
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The WHO filings take the number of Ranbaxy anti-retrovirals (ARVs) submitted to the authority to five, while the FDA filing, which has been submitted under the FDA’s expedited review process for the President’s emergency program for AIDS relief (PEPFAR), takes the total number of ARV filings with the FDA to four.
Speaking on the development, Dr Brian Tempest, CEO and managing director of Ranbaxy Laboratories Limited, said, “Ranbaxy remains committed towards refiling its ARVs with the WHO and the US FDA, under the PEPFAR Program. By this summer, we expect most of our range of HIV medicines to be filed with WHO and US FDA. This is yet another step in making these quality medicines available widely in countries that urgently need them.”