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Published on 11/7/2005 in the Prospect News Biotech Daily.

Aurobindo Pharma receives tentative FDA approval for Lamivudine

By Jennifer Chiou

New York, Nov. 7 - Aurobindo Pharma Ltd. said the U.S. Food and Drug Administration granted tentative approval for its Lamivudine oral solution.

Lamivudine is an antiviral drug called a nucleoside reverse transcriptase inhibitor for infections due to hepatitis B and in combination with other medications for human immunodeficiency virus.

Aurobindo noted Lamivudine is the first generic version to be approved of Epivir oral solution produced by GlaxoSmithKline.

Including Lamivudine, the company has eight product approvals under president George Bush's Emergency Plan for AIDS Relief program.

The Hyderabad, Andhra Pradesh, India, company makes generic pharmaceuticals and pharmaceutical ingredients.


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