Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Update on FDA Warning Letter
Date:11/21/2008

DETROIT, Nov. 21 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Alternext US: CPD) announced today 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.

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. to Market Generic Sinemet(R) Tablets
2. Caraco Pharmaceutical Laboratories, Ltd. Reaches Agreement with Labor Union
3. Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Depakote(R) Delayed Release Tablets
4. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Elavil(R)
5. Caraco Pharmaceutical Laboratories, Ltd. Reports Record Results for the Fourth Quarter and Fiscal Year 2008
6. Caraco Pharmaceutical Laboratories, Ltd. to Announce Fourth Quarter and Fiscal Year 2008 Results on May 29, 2008
7. Caraco Pharmaceutical Laboratories Ltd. Wins Summary Judgment on Generic Ultracet(R)
8. Caraco Pharmaceutical Laboratories Ltd. To Market Generic Ethyol(R)
9. Caraco Pharmaceutical Laboratories Ltd. to Market Generic Protonix(R)
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Metaglip(R)
11. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Childrens Zyrtec(R) Chewable Tablets for Allergy Relief and Childrens Zyrtec(R) Chewable Tablets for Hives Relief
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... ... February 05, 2016 , ... Regular gym users know the ... to wait longer to access the treadmills. It’s a predictable trend. After the excesses ... weight and get in shape by joining gyms, starting new walking or running routines, ...
(Date:2/5/2016)... ... February 05, 2016 , ... Dr. Justin Scott and Dr. Lydia ... No Cost Dental Day to individuals in need. The event is scheduled to take ... Cost Dental Day is to provide dental care to community members in need. Each ...
(Date:2/5/2016)... ... February 05, 2016 , ... Health and wellness is a topic that should ... event they are experiencing an illness. Migraines are a severe form of a headache ... migraines would not wish the pain on their worst enemy, the feeling can last ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... –This week, ... the benefits of having a tankless water heater. To view the report, click ... heaters: tank and tankless. While each has their pros and cons, the type chosen ...
(Date:2/4/2016)... ... 04, 2016 , ... American Addiction Centers (AAC) and Holdspace ... Project HoldSpace. Through the partnership, the two organizations seek to tackle the widespread ... ages of 13 and 18. Currently focused on Ohio schools, the first leg ...
Breaking Medicine News(10 mins):
(Date:2/5/2016)... Calif. , Feb. 5, 2016  Syneron ... global aesthetic device company, announced today that ... Candela North America, is scheduled to participate in ... Healthcare Conference on February 11, 2016 in ... will allow institutional investors to meet with the ...
(Date:2/5/2016)... Feb. 5, 2016  Patients in Alabama ... ultrasound (HIFU) therapy no longer have to travel out of ... partnership with Urology Centers of Alabama to provide ... procedure for qualifying patients. Alabama ... the treatment of prostate cancer using many different modalities. They ...
(Date:2/5/2016)... 5, 2016 Aethlon Medical, Inc. (Nasdaq: AEMD ... CEO, will be presenting at Source Capital Group,s 2016 Disruptive ... at 2:15 p.m. ET on Wednesday, February 10, ... discussion taking place at 3:15 p.m. ET. http://www.aethlonmedical.com ... hour after the conclusion of the live event. The panel ...
Breaking Medicine Technology: