Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
Date:9/5/2007

DETROIT, Sept. 5 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg (Carvedilol).

Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of left ventricular dysfunction following myocardial infarction in clinically stable patients, and hypertension. This new product is the bioequivalent to Coreg(R), a registered trademark of GlaxoSmithKline. Coreg(R) had U.S. sales of approximately $1.59 billion for the 12-month period ended June 30, 2007, according to IMS Data.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to receive this approval from the FDA. This marks the fifth approval this quarter in addition to the two tentative approvals we have gained during the period. Our focus continues to be working towards broadening our portfolio by expanding our product offerings as effectively as possible. We plan to market this product immediately. This will bring our total product selection to 39 different products represented by 82 various strengths."

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©2007 PR Newswire.
All rights reserved

Related medicine news :

1. South Africa Wins landmark case against pharmaceutical giants
2. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
3. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
4. Setting up a new pharmaceutical industry in India
5. Medicis Pharmaceutical company enters pediatric market
6. Supply of Radiopharmaceuticals Hampered by Attacks
7. Pharmaceutical companies are targeting patients
8. FDA approves Watson Pharmaceuticals Oxytrol patch
9. Ranbaxy Pharmaceuticals Inc awarded the prestigious outstanding supplier award received from Wal-Mart
10. Indian Pharmaceutical Industries Stops Manufacturing And Sale Of Valdecoxib
11. Pharmaceutical industries grant for R&D to be monitored
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... ... February 10, 2016 , ... The recreational use of ... in the state still face a lot of restrictions as to where they can ... for private, personal use” and that cannabis “may not be consumed openly or publicly.” ...
(Date:2/10/2016)... , ... February 09, 2016 , ... A new leadership ... Summer 2016. FHU President Joe Wiley made the announcement Monday night, Feb. 8, prior ... a 2003 graduate of FHU and the creator of GO! Camp, has been named ...
(Date:2/10/2016)... ... February 09, 2016 , ... Ross A. ... are delighted to welcome a new addition to their growing practice. Beginning this ... as a nurse practitioner performing cosmetic procedures including injectables, fillers and ...
(Date:2/10/2016)... Franklin, TN (PRWEB) , ... February 09, 2016 ... ... related to sports concussion, yet the cause of injury may be one of ... This two-day advanced PT Continuing Education Course , Mastering Rehab Solutions ...
(Date:2/9/2016)... Florida (PRWEB) , ... February 09, 2016 , ... Steven ... the Taste of South Florida Event, an upscale fundraiser held in South Florida. The ... sponsors and guests alike. This year the event will be held in a new, ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... Feb. 10, 2016  Astellas Pharma Inc. (TSE: 4503, ... today that it has successfully completed, through its indirect ... to purchase all issued and outstanding shares of common ... CEO: Paul Wotton , "Ocata") for a price ... cash ("Tender Offer"). Astellas commenced the Tender Offer on ...
(Date:2/10/2016)... 2016 Puerto Rico Healthcare and Life ... Healthcare and Life Sciences Report 2016 . --> ... Rico Healthcare and Life Sciences Report 2016 . ... largest territory in the world for pharma manufacturing, a territory ... manufacturing, and more universities per square mile than anywhere else ...
(Date:2/10/2016)... , Feb. 10, 2016 Mast ... developing novel, clinical-stage therapies for sickle cell disease and ... public offering of 29,090,910 units at a price to ... of one share of the Company,s common stock and ... common stock at an exercise price of $0.42 per ...
Breaking Medicine Technology: