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news.The FDA has granted tentative approval to Caraco Pharmaceutical Laboratories' application to market a generic version of a Sanofi-Aventis insomnia treatment.
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Firm approval of Caraco’s amended new drug application for zolpidem tartrate, 5mg and 10mg tablets, is anticipated after the patent for Sanofi-Aventis’ Ambien brand expires in October 2006.
Total annual US sales of the brand product for both strengths are approximately $2 billion for all indications, and Caraco will hope to take a slice of this when its generic version of the drug is brought to market.
“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 Movens, CEO, Caraco. “This tentative approval will be a positive addition to our current portfolio of products,” he added.
Detroit-based Caraco Pharmaceutical Laboratories, develops, manufactures and distributes generic and private-label prescription drugs to the nation’s wholesalers, distributors, drugstore chains and healthcare systems.