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:7/12/2014)... “After my mom’s stroke, she loss the use ... loss the use of his left side. Eating became a difficult ... help people like them enjoy eating again,” said an inventor, from ... PATRICIA CAROL HALL PLATE (P C H PLATE). , The PATRICIA ... way to eat for individuals who suffer from stroke, experience tremors ...
(Date:7/12/2014)... With prom shopping reaching its final days, VogueQueen.com, a ... showcase its new and trendy apparels. Recently, the company ... its online shop. Additionally, it is now providing huge ... According to the company’s sales manager, the promotion will ... , He says, “Now, worldwide clients can order cheap ...
(Date:7/12/2014)... 2014 “Critical Care Therapeutics in ... Late-Stage Four-Factor PCCs and Recombinant Products to Drive ... care market in the US, UK, France, Germany, ... an estimation of market size for 2013, along ... care indications that are being treated using the ...
(Date:7/12/2014)... 2014 Utah Valley Entrepreneurial Forum Top ... awards being bestowed to companies in revenue, and pre-revenue ... community with recognition for new ideas as well as ... revenue. , 25 Under 5 highlights outstanding Utah entrepreneurs ... under 5 years old. Award recipients were recognized at ...
(Date:7/12/2014)... 12, 2014 Praeclarus Press ... as a valuable new resource for women in need ... American women work away from their children. Today’s mothers ... benefits of breastfeeding, but often feel unsupported when it ... babies. With its evidence-based insights, and written by Nancy ...
Breaking Medicine News(10 mins):Health News:VogueQueen.com Updates Its Summer Collection With New And Trendy Evening Dresses 2Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 2Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 3Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 4Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 5Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 6Health News:SquareHook is Recognized for UVEF 25 Businesses Under 5 Years-Watch Out 2Health News:Praeclarus Press Announces the Release of Working and Breastfeeding Made Simple by Nancy Mohrbacher, A Much Needed Resource For Today's Working Mothers 2
... with highest levels are more apt to have joint replacement, ... of a certain protein strongly predict the risk of hip ... a new study shows. , The research involved 912 healthy ... led to a knee or hip replacement between 1990 and ...
... /PRNewswire/ - rL Solutions, the leading provider of healthcare ... be sponsoring the 2009 MITSS HOPE Award. MITSS and ... 8th Annual Dinner and Fundraiser on Thursday, November 12, ... MITSS established this award in 2008 to recognize people ...
... , , , ... Francisco SPCA ( www.sfspca.org ), the city,s leading privately supported, ... and safety. , , Whether traveling out of ... The SF/SPCA offers this guide for quick and easy reference: ...
... , , , , ... On Tuesday, Governor Schwarzenegger line-item vetoed the Department of Public Health,s ... domestic violence shelters and centers. , , ... advocacy, assistance with restraining orders, counseling and other vital support services. ...
... R.I., July 30 CVS/pharmacy, the nation,s largest retail pharmacy, announced ... with visual impairments and other disabilities. The Company has installed ... website in 2009. , , ... , Today,s announcement is the result of a ...
... patients (three male and seven female) with hepatic angiomyolipoma, ... 19-78 years). Of these patients, dynamic contrast CT showed ... density, absence of a capsule, and prominent central vessels ... with or without a fat component in four cases ...
Cached Medicine News:Health News:Biomarker Could Predict Severe Osteoarthritis 2Health News:rL Solutions to Sponsor 2009 MITSS HOPE Award 2Health News:The San Francisco SPCA Launches Online Guide for Summer Pet Health & Safety 2Health News:The San Francisco SPCA Launches Online Guide for Summer Pet Health & Safety 3Health News:Governor Eliminates Funding to Domestic Violence Programs 2Health News:CVS/pharmacy Enhancing Accessibility for the Visually Impaired To Its Web Site and Store Point of Sales Devices 2Health News:CVS/pharmacy Enhancing Accessibility for the Visually Impaired To Its Web Site and Store Point of Sales Devices 3Health News:CVS/pharmacy Enhancing Accessibility for the Visually Impaired To Its Web Site and Store Point of Sales Devices 4
(Date:7/11/2014)... 11, 2014 On Thursday, ... 0.52%, the Dow Jones Industrial Average finished the day 0.42% ... down 0.41%. The losses were broad based as eight out ... 500 Health Care Sector Index ended the day at 711.88, ... last one month. Investor-Edge has initiated coverage on the following ...
(Date:7/11/2014)... 2014 Neurelis, Inc. ("Neurelis") today announced an ... option held by Biotie to purchase Neurelis, clearing the ... (intranasal diazepam) for pediatric and adult epilepsy patients who ... year, Biotie has advanced the development program for NRL-1 ... clinical work required for NDA submission to the FDA.  ...
(Date:7/10/2014)... Integrated Silicon Solution, Inc. (Nasdaq: ... IC solutions, today announced that it will host its ... 7:00 a.m. Pacific Time (10:00 a.m. Eastern Time) to ... third quarter ended June 30, 2014. To ... 6:50 a.m. Pacific time on July 24, 2014.  The ...
Breaking Medicine Technology:Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 2Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 3Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 4Neurelis Regains Rights to Intranasal Diazepam Program 2Neurelis Regains Rights to Intranasal Diazepam Program 3
... Nov. 15, 2011 Reportlinker.com announces that ... in its catalogue: ... India & China ... emerging economies represent a combined pharmaceutical market ...
... Pa, Nov. 15, 2011 As any purchasing manager knows, ... shipping options is time lost. When purchasing surgical instruments ... In January of 2010, Robert Edelstein, President of Millennium ... Saints Charities seeking a vendor for eye surgical instruments ...
Cached Medicine Technology:The Outlook for Pharmaceuticals in Brazil, Russia, India & China 2The Outlook for Pharmaceuticals in Brazil, Russia, India & China 3The Outlook for Pharmaceuticals in Brazil, Russia, India & China 4The Outlook for Pharmaceuticals in Brazil, Russia, India & China 5Millennium Surgical Corp. Provides Instruments to Latter Day Saints Charities for Humanitarian Projects 2
Hard protective shields for post-operative or post-injury use. Universal, or Left/Right specific. Packaged 12 per box....
Hard protective shields for post-operative or post-injury use. Universal, or Left/Right specific. Packaged 12 per box....
Hard protective shields for post-operative or post-injury use. Universal, or Left/Right specific. Packaged 12 per box....
... The Wet-Field Coagulator provides precise episcleral, ... peripheral tissue trauma. Controlled Rf diathermy ... comprehensive line of bipolar Eraser instruments, ... enhanced features that ensure a high ...
Medicine Products: