Caraco Pharmaceutical Laboratories

U.S. FDA grants tentative approval for Zolpidem Tartrate

Published in Law and Health Weekly, October 1st, 2005

Caraco Pharmaceutical Laboratories, Ltd., (CPD) announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the company's abbreviated new drug application (ANDA) for Zolpidem Tartrate, 5mg and 10mg tablets.

Final approval of this product is anticipated subsequent to the expiry of patent protection in October 2006.

Caraco's Zolpidem Tartrate is the generic equivalent of Sanofi's short-term treatment of insomnia product, Ambien.

"We are extremely pleased with receiving this tentative approval and look forward to the expiration date of the patent in October 2006, allowing Caraco to market the...

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Source: Law and Health Weekly (2005-10-01)

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