Aurobindo gets FDA approval for Stavudine capsules

By Elaine Rigoli

Tampa, Fla., June 29 - Aurobindo Pharma Ltd. has received tentative approval from the Food and Drug Administration for Stavudine capsules, 15 mg and 20 mg.

This is in addition to 30 mg and 40 mg capsules already approved in July 2005.

This new FDA action tentatively approves the total application covering 15, 20, 30 and 40 mg.

Stavudine is an antiviral agent of the nucleoside analog class, which includes zidovudine, known as AZT, didanosine and zalcitabine.

The international brand name is Zerit and is marketed by Bristol Myers Squibb. Nucleoside analogs are thought to slow the progression of AIDS by inhibiting HIV replication.

Data indicate that this class of drugs may delay the onset of AIDS symptoms in HIV-infected individuals and may extend survival in some.

Aurobindo is a pharmaceutical company based in Hyderabad, India.

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