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:9/20/2017)... ... September 20, 2017 , ... In just a short time ... already been receiving positive feedback from customers trying the product for the first time, ... Brain Booster was developed by neurosurgeon Shawn Moore, MD, for everyone from athletes at ...
(Date:9/20/2017)... ... ... The Centers for Medicare and Medicaid Services (CMS) stated in the Inpatient ... Worksheet S-10 to distribute Disproportionate Share Hospital (DSH) Uncompensated Care Payments over the next ... on October 17, 2017 at 2 P.M. EST and uncover how you can prepare ...
(Date:9/20/2017)... ... September 20, 2017 , ... ... feel good program from Leany Greeny delivers positive results in just three weeks. ... health and kickstart the metabolism. Fitting seamlessly into hectic work and family schedules, ...
(Date:9/20/2017)... ... September 20, 2017 , ... “Finn Mouseson”: follows the exciting ... an average life. This mouse sets out on a journey that will show that ... is the creation of newly published author and illustrator, Melody Gersonde-Mickelson, who has earned ...
(Date:9/20/2017)... (PRWEB) , ... September 20, 2017 , ... “Psalms of ... give peace of mind and move the readers one step closer to God. “Psalms ... has realized that his mistakes that have been made within his life are the ...
Breaking Medicine News(10 mins):
(Date:9/6/2017)... , Sept. 6, 2017 NeuroRx, a clinical ... Suicidal Ideation and Behavior (ASIB), has been granted Fast Track ... sequential therapy of NRX-100 (ketamine HCl) followed by NRX-101 (D-cycloserine ... a pivotal trial of this sequential therapy targeting patients who ... 1 ...
(Date:9/5/2017)... , Sept. 5, 2017  Just 18 months ... Insight is pleased to announce the appointment of three ... Tammy Wynne , Dominic Jones-Phillips and ... industry. Tammy ... team of market access writers. She has over ten ...
(Date:8/31/2017)... PM360,s annual Innovations Issue, published in ... innovations happening across the industry. Established six years ago, ... providing a comprehensive look at the newest and most ... innovative companies, startups, divisions, products, services, and strategies from ... "Everyone in this industry wants to do better—in all ...
Breaking Medicine Technology: