Caraco Pharmaceutical Laboratories, Ltd. Update on FDA Warning Letter
December 1st, 2008
2008 DEC 1 -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Alternext US: CPD) announced that it will be filing its response to the FDA warning letter on November 24, 2008 as planned. In the warning letter, received on October 31, 2008, the FDA requested a response from Caraco within 15 business days, ending November 24, 2008.
As previously disclosed, the warning letter was issued as a follow up to the last FDA inspection of the Company's manufacturing facility in Detroit, Michigan which was initiated in May 2008. Until the Company's responses to the observations have been clarified and explanations provided to the satisfaction of the FDA, the FDA may in the near term withhold approval of pending new drug applications listing the facility as the manufacturer. The Company's sales of current products continue in the normal course of business.
The Company is committed to working cooperatively and expeditiously with the FDA to resolve the matters indicated in its letter.
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.
Keywords: FDA, Pharmaceuticals, Regulatory Actions, U.S. Food and Drug Administration, Caraco Pharmaceutical Laboratories Ltd.
This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2008, Biotech Business Week via NewsRx.com.
