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
'/>"/>

SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

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:9/23/2014)... a driving force behind many chronic diseases, especially ... inflammation caused by conditions such as viral hepatitis ... options. Now, scientists at Virginia Commonwealth University Massey ... in preclinical studies that blocking the expression of ... halts the development and progression of liver cancer ...
(Date:9/23/2014)... Wellesley, Mass., September 23, 2014 – BCC Research ( ... Joint Reconstruction and Replacement: Materials, Technologies, and Global Markets ... is expected to increase to nearly $16.2 billion by ... 4.2% from 2013 through 2018. The U.S. occupies the ... CAGR of 5.1%. , Revision and partial joint replacement ...
(Date:9/23/2014)... eCaring, a leading health care quality ... contract to provide its unique Web-based home health care ... New York City’s largest not-for-profit health plans. Elderplan, an ... to help enhance the care of its Medicare, Medicaid ... Elderplan has been at the forefront of offering New ...
(Date:9/23/2014)... NY (PRWEB) September 23, 2014 ... revenue for the Fruit and Vegetable Markets ... consumption and fruit prices benefited operators over the ... industry follow unique preference and demographic trends, including ... US population. While per capita fruit and vegetable ...
(Date:9/23/2014)... the results of their cancer research at ESMO ... Joint Symposium: ESMO-ASCO: The Evolution of the ... AM - 12:30 PM, Room: Granada, Abstract 121IN: ... new forms of cancer clinical research? The example ... Paper session: Melanoma and other skin tumors , ...
Breaking Medicine News(10 mins):Health News:Study uncovers genetic driver of inflammation, uses it to prevent and treat liver cancer 2Health News:Global Market for Joint Reconstruction and Replacement to reach $16.2 Billion in 2018; The U.S. Market Moving at 5.1% CAGR 2Health News:Global Market for Joint Reconstruction and Replacement to reach $16.2 Billion in 2018; The U.S. Market Moving at 5.1% CAGR 3Health News:eCaring Signs Care Management Contract with Elderplan, Inc. 2Health News:Fruit & Vegetable Markets in the US Industry Market Research Report from IBISWorld Has Been Updated 2Health News:Fruit & Vegetable Markets in the US Industry Market Research Report from IBISWorld Has Been Updated 3Health News:EORTC presentations at ESMO 2014 Congress 2Health News:EORTC presentations at ESMO 2014 Congress 3
... new study has established the wholesomeness of whole wheat ... breast cancer risk in the offspring.// ,Dr ... her colleagues examined the benefits of dietary changes on ... health. These results could well mimic the occurrence in ...
... health care for patients that was released by the ... countries, except the U.S. ,In the survey ... was found that Canada lagged in several aspects including ... doctors availability after hours, multi-discipline teams for treatment of ...
... to arouse strong feelings either way has been brought up ... the proposal suggests mercy killing of// new borns who are ... Gynaecology put forth this recommendation as the solution to the ... are being kept alive because of the advanced technology ...
... 7 and the theme selected is Cancer and Women. ... on that day// to promote awareness and motivate people ... ,"Run 4 Cancer" will be flagged off by SSP ... Allahabad Division RN Tripathi will preside over a lecture ...
... a biotechnology firm based in Seattle has called off further ... year following the untimely deaths// of few of the patients ... efficacy of the cancer drug Xyotax. ,The CEO of ... the volunteer s who were cancer patients do not seem ...
... raising the retirement age for civil servants from 60 to ... soaring pension bill//. ,Moreover, improving health standards and ... retiring are being cited among the reasons for the move. ... Reforms (NCGR) told The News International that the reform body ...
Cached Medicine News:Health News:Consider Euthanasia For Severely Disabled Babies, College Tells Doctors 2Health News:Awareness about Women's Cancers- A National Concern 2Health News:Multiple deaths forces cancer trial to be called off 2Health News:Pakistan civil servants may retire at 62 2
(Date:9/23/2014)... , Sept. 23, 2014  SiteOne Therapeutics Inc. today ... financing. Led by Sears Capital Management and Biobrit LLC, ... Zakrzewski , the $1.5 million financing positions SiteOne to ... pain and to further develop its technology platform for ... In conjunction with the financing, Lowell ...
(Date:9/23/2014)... According to the new ... Ultrasound, Irreversible Electroporation, Cryotherapy, Microwave), Application (General & ... Forecasts to 2019", published by MarketsandMarkets, studies the global ... 2014 to 2019. The market is expected to ... 9.6% from 2014 to 2019. Browse ...
(Date:9/23/2014)... , Sept. 23, 2014 CASI Pharmaceuticals, ... dedicated to the acquisition, development and commercialization of innovative ... the global market with a primary focus on ... Rajesh C. Shrotriya , MD, Chairman and Chief Executive ... Directors.  The appointment was made in connection with the ...
Breaking Medicine Technology:SiteOne Therapeutics Completes $1.5M Initial Round of Equity Financing, Secures $1.4M NIH Grant 2SiteOne Therapeutics Completes $1.5M Initial Round of Equity Financing, Secures $1.4M NIH Grant 3Ablation Technologies Market Worth $3.81 Billion by 2019 2Ablation Technologies Market Worth $3.81 Billion by 2019 3Ablation Technologies Market Worth $3.81 Billion by 2019 4CASI Pharmaceuticals Announces Appointment Of Rajesh C. Shrotriya, MD To The Board Of Directors 2CASI Pharmaceuticals Announces Appointment Of Rajesh C. Shrotriya, MD To The Board Of Directors 3CASI Pharmaceuticals Announces Appointment Of Rajesh C. Shrotriya, MD To The Board Of Directors 4
... 2010 Diopsys, Inc. today announced the development of ... (SD-OCT) images to assist ophthalmologists and optometrists in diagnosing ... SD-OCT is an imaging technique used to ... Nerve Fiber Layer (RNFL) which can help them diagnose ...
... 20, 2010 A small Midwest college that is producing ... a $35 million grant from Lilly Endowment to launch a ... northern Indiana, has a Nobel Laureate in chemistry, the inventor ... and the first female commissioner of the U.S. Food and ...
Cached Medicine Technology:New Software for Improving the Analysis of OCT Images 2Manchester College Receives $35 Million Grant From Lilly Endowment for School of Pharmacy 2Manchester College Receives $35 Million Grant From Lilly Endowment for School of Pharmacy 3
... Finntip Filters are ideal for ... or for any work where ... are designed for pipetting DNA/RNA ... and other. For applications requiring ...
Inquire...
... aerosol contamination, which causes ... PCR. Hydrophobic, nonwicking and ... can pass through these ... contrast to tips with ...
... offer a safe alternative to using positive ... applications such as PCR(a), pipetting radioactive materials ... are excellent for tissue culture, gel loading, ... prevent aerosol contaminants and liquids from reaching ...
Medicine Products: