The US Food and Drug Administration has granted tentative approval for Caraco Pharmaceutical Laboratories’ 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 product," said Daniel H. Movens, CEO.
Total annual US sales of the brand product for both strengths are approximately $2.0 billion for all indications.
Caraco operates an R&D Centre at its Detroit headquarters complex and receives R&D support from Sun Pharmaceutical Industries, Ltd., India's fifth largest pharmaceutical firm.