FDA News

Caraco Pharmaceutical Laboratories Ltd. Announces FDA Approval to Market Generic Ambien

(April 24, 2007)-- Caraco Pharmaceutical Laboratories announced that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Zolpidem Tartrate Tablets.

Zolpidem Tartrate is a sedative-hypnotic drug, which is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. This new product is the bioequivalent to Ambien, a registered trademark of Sanofi-aventis. Ambien had U.S. sales of approximately $2.09 billion for the 12-month period ended Dec. 31, 2006, according to IMS Data. Caraco has two strengths available, 5 mg and 10 mg tablets.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "An essential part of our core business strategy is to broaden our portfolio by expanding our product offerings. This is our first sedative-hypnotic product and we are pleased that this will complement our current portfolio. We plan to launch this product to the market immediately. This will bring our total product selection to 29 different products represented by 65 various strengths."

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Share or bookmarklet this web page at: