Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Responds to FDA Warning Letter
Date:11/24/2008

DETROIT, Nov. 24 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Alternext US: CPD) announced today that it has timely submitted its response to the FDA warning letter that was received on October 31, 2008. In the warning letter, 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. The Company has requested a meeting with the FDA as a follow up to its response. Caraco believes it has addressed the concerns in the warning letter appropriately.

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.

Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission, including Item 1A to the Corporation's annual report on Form 10-K, and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or less expensive products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward- looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.


'/>"/>
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Caraco Pharmaceutical Laboratories, Ltd. Update on FDA Warning Letter
2. Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Sinemet(R) Tablets
3. Caraco Pharmaceutical Laboratories, Ltd. Reaches Agreement with Labor Union
4. Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Depakote(R) Delayed Release Tablets
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Elavil(R)
6. Caraco Pharmaceutical Laboratories, Ltd. Reports Record Results for the Fourth Quarter and Fiscal Year 2008
7. Caraco Pharmaceutical Laboratories, Ltd. to Announce Fourth Quarter and Fiscal Year 2008 Results on May 29, 2008
8. Caraco Pharmaceutical Laboratories Ltd. Wins Summary Judgment on Generic Ultracet(R)
9. Caraco Pharmaceutical Laboratories Ltd. To Market Generic Ethyol(R)
10. Caraco Pharmaceutical Laboratories Ltd. to Market Generic Protonix(R)
11. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Metaglip(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... ... February 24, 2017 , ... With ProGlass Prism users ... X . Users have total control over position, rotation, distortion, edge softness, edge blur, ... Final Cut Pro X. , With ProGlass Prism users are given the tools ...
(Date:2/24/2017)... ... February 24, 2017 , ... Indiana Fiber Network (IFN) President and CEO ... year. Dyer started as the Chairman of the Management Committee when IFN was ... corporation including the recruitment of investor/owners and development of the business plan. He ...
(Date:2/24/2017)... ... February 24, 2017 , ... Castle Farms, ... their Military Wedding Giveaway, with the winning couple announced on Feb. 14, 2017, ... generously donated from local vendors: A Matter of Taste, Ryan Rousseau Enterprises, A ...
(Date:2/23/2017)... ... February 23, 2017 , ... The ... funding innovative lymphoma research and serving the lymphoma community through a comprehensive series ... La Gorce Country Club in Miami Beach to host its Swirl: Miami Wine ...
(Date:2/23/2017)... ... February 23, 2017 , ... Hamlin Dental Group and Dr. Hamid Reza, ... a raffle. Throughout the month of February, patients who visit Hamlin Dental Group will ... a dinner for two at the Cheesecake Factory. , Tickets are available for ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... Research and Markets has announced the addition of the ... to 2025" report to their offering. ... The Global Wireless Health Market is ... next decade to reach approximately $330.5 billion by 2025. ... the given segments on global as well as regional levels presented ...
(Date:2/24/2017)... 2017 Research and Markets has announced the addition ... Forecast to 2025" report to their offering. ... The Global Empty Capsules Market is poised to ... reach approximately $2.9 billion by 2025. This industry report ... global as well as regional levels presented in the research scope. The ...
(Date:2/24/2017)... 2017 Research and Markets has announced the addition ... report to their offering. ... The latest research Dry eye Drugs Price Analysis and Strategies - ... market. The research answers the following questions: ... clinical attributes? How are they positioned in the Global Dry eye market? ...
Breaking Medicine Technology: