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Ranbaxy expedited HIV generics

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Ranbaxy will begin filing its full range of generic antiretroviral HIV drugs before the end of 2004 under the Emergency Plan for AIDS Relief, the firm says Aug. 2. The $15 bil. Bush Administration plan, announced in May, provides for an expedited review process; a draft guidance on fixed-dose combination and co-packaged HIV/AIDS drugs sets a formal six-month review period, but FDA's goal is to review combo products in six weeks...





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