Navigation Links
Caraco Pharmaceutical Laboratories Ltd. To Market Generic Ethyol(R)
Date:3/31/2008

DETROIT, March 31 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (Amex: CPD) announced today, that it has launched amifostine for injection 500mg on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma). This product has been added to Caraco's Paragraph IV marketing agreement with Sun Pharma that was signed on January 29, 2008. Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Ethyol(R), and being the first-to-file an ANDA with a Paragraph IV certification, has a 180-day marketing exclusivity. Sun Pharma is currently involved in patent litigation with MedImmune Oncology, Inc. concerning this product in the U.S. District Court for the District of Maryland.

Amifostine is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with ovarian cancer. This new product is bioequivalent to Ethyol(R), a registered trademark of MedImmune Oncology, Inc. Ethyol(R) had U.S. sales of approximately $80 million for the 12-month period ended December 31, 2007, according to IMS Data.

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 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 cheaper 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. Announces FDA Approval to Market Generic Version of Zyloprim(R)
2. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
3. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
4. Caraco Pharmaceutical Laboratories Ltd. Announces Tentative FDA Approval for Generic Zyrtec Chewable(R)
5. Caraco Pharmaceutical Laboratories Ltd. Reports Record Net Sales for the Second Quarter and First Six Months of Fiscal 2008
6. Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lamictal(R)
7. Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lexapro(R)
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Norvasc(R)
9. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Zyrtec Allergy Tablets(R) and Zyrtec Hives Relief Tablets(R)
10. 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
11. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Metaglip(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history ... The Brink” is the creation of published author, William Nowers. Captain Nowers and ... WWII veteran, he spent thirty years in the Navy. Following his career as ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
(Date:10/12/2017)... ... 12, 2017 , ... Information about the technology: , Otomagnetics ... enable prevention of a major side effect of chemotherapy in children. Cisplatin and ... For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. ...
(Date:10/12/2017)... Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... is holding a treadmill relay – Miles by Moonlight to raise money for the ... donating $300 or more. , Teams will work together to keep their treadmills ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... the latest in wound care advancements to physician colleagues, skilled nursing facility medical ... titled, "Navigating the Treacherous Waters of Wound Care." , "At many of these ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... , Oct. 4, 2017 ... single-use, self-contained, illuminating medical devices, today announced regulatory ... Health Surveillance Agency (or Agência Nacional de Vigilância ... first single-use, cordless surgical retractor with integrated LED ... optimal access, illumination and exposure of a tissue ...
(Date:10/2/2017)... -- The Rebound mobile app is poised to become a ... of prescription drug addiction. The app empowers users to develop ... down their dosage in a safe, controlled manner while maximizing ... first 100,000 people to sign up will enjoy 3 months ... ...
(Date:9/25/2017)... , Sept. 25, 2017   Montrium ... Master File solutions, today—from the IQPC Trial Master ... , NL)—announced that EastHORN Clinical Services has ... clinical programs and TMF management. EastHORN, a leading ... eTMF platform to increase transparency to enable greater ...
Breaking Medicine Technology: