Financial Daily from THE HINDU group of publications
Sunday, Jul 03, 2005
Financial Daily from THE HINDU group of publications Sunday, Jul 03, 2005 |
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Corporate
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Announcements Aurobindo Pharma's generic AIDS drug gets USFDA nod Our Bureau
Hyderabad , July 2 AUROBINDO Pharma Ltd (APL), the Hyderabad-based pharma major, has obtained tentative approvals of the United States Food and Drug Administration (USFDA) for its anti-AIDS drug `Stavudine', a generic version of the Bristol-Myers Squibb drug `Zerit'. This is the fourth anti-AIDS drug from APL to be approved by US regulators in the recent past. According to company officials, the US regulator gave its tentative approval for Stavudine on Friday. The drug is part of a category known as nucleoside reverse transcriptase inhibitors, which help in suppressing the HIV virus - the cause of AIDS. The USFDA's tentative approval implies that `Stavudine' meets all the standards prescribed by it that include quality, safety and efficacy for marketing the drug in the US market. However, the drug cannot be sold in the US market in view of the existing patents and exclusive marketing rights of other pharma companies. The USFDA approval makes `Stavudine' available for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR). Incidentally, another USFDA approval to APL on Efavirenz, the generic version of Sustiva tablets is also manufactured by Bristol-Myers Squibb.
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