Indian Generic Drug Maker Strides Acrolab Receives Tentative FDA Approval For Combination Antiretroviral

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 27 Mar 2008 - 5:00 PST

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FDA on Tuesday announced that it has given tentative approval to Indian generic pharmaceutical company Strides Acrolab for its fixed-dose antiretroviral drug that contains lamivudine, nevirapine and stavudine, Reuters/Yahoo! Malaysia News reports (Reuters/Yahoo! Malaysia News, 3/26). Tentative FDA approval means that although existing patents or other issues prevent marketing of the drug in the U.S., the drug is qualified for consideration in the President's Emergency Plan for AIDS Relief (FDA release, 3/24). The FDA approval is for multiple strengths of the combination therapy, according to Dow Jones (Dow Jones, 3/24). The two versions are 30 milligrams, 150 mg and 200 mg of stavudine, lamivudine and nevirapine, respectively, and 40 mg, 150 mg and 200 mg of stavudine, lamivudine and nevirapine, respectively (FDA release, 3/24).

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