The Hindu Business Line : Aurobindo gets FDA approval for new drug

Hyderabad, Dec. 31 Aurobindo Pharma has got final approval for two of its Abbreviated New Drug Applications (ANDAs) for Stavudine Capsules and Stavudine for oral solution from the US Food & Drug Administration (USFDA).

The Stavudine capsules would be in 15 mg, 20 mg, 30 mg and 40 mg dosages while the oral solution would be 1 mg/ml, according to a company press release.

The two products in the dosages mentioned are the generic equivalent of Bristol-Myers Squibb’s Zerit. These fall under the anti-retroviral (ARV) segment and are indicated for treatment of HIV-1 infection in combination with other ARVs.

The market size has been estimated at approximately $1 million for the 12 months ending June, 2008, according to Newport.

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