Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Norvasc(R)
Date:12/5/2007

DETROIT, Dec. 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 Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mg (Amlodipine).

Amlodipine is indicated for the treatment of hypertension, for the symptomatic treatment of chronic stable angina, and for the treatment of confirmed or suspected vasospastic angina. Amlodipine is the bioequivalent to Norvasc(R), a registered trademark of Pfizer Inc. According to IMS Data, based upon the most recent quarterly sales ended September 2007, Amlodipine generic and brand products combined have a run rate of approximately $550 million with ten generic competitors.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "This product marks our seventh final approval since June 30, 2007. We are evaluating the market place and internal production planning in an effort to monetize this approval as soon as possible. This will bring our total product selection to 43 different products represented by 92 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. 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. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
9. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
10. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
11. National Pharmaceutical Council Announces New Strategic Focus, Search for New Leadership
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... Las Vegas, Nevada (PRWEB) , ... October 13, 2017 , ... ... of 7® Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum ... CBD dose required and providing a CBD form that can be easily incorporated into ...
(Date:10/13/2017)... ... 2017 , ... Many families have long-term insurance that covers care for a ... waiver for care if the client has a cognitive impairment diagnosis. , “What ... is often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Yisrayl Hawkins, Pastor ... that explains one of the most popular and least understood books in the Holy ... and puzzling descriptions that have baffled scholars for centuries. Many have tossed it off ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history of ... Brink” is the creation of published author, William Nowers. Captain Nowers and his ... veteran, he spent thirty years in the Navy. Following his career as a ...
(Date:10/12/2017)... ... 2017 , ... The company has developed a suite of ... authorities worldwide. From Children’s to Adults 50+, every formula has been developed by ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, Preservative ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)...  NDS received FDA 510(k) clearance in May 2017 for its ... specifically designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... to support the improvement of patient outcomes, procedural efficiency, and the ... ... ...
(Date:10/4/2017)... -- According to the Centers for Disease Control and Prevention (CDC), influenza ... Care is helping communities across Massachusetts , ... no-cost* flu shots through the end of the month. *Some ... ... flu shot is by the end of October, according to the Centers ...
(Date:10/2/2017)... 2, 2017 Halo Labs announces the European launch of ... the HORIZON at MIBio 2017 in Cambridge, U.K ... particulate matter in biopharmaceutical samples with unprecedented speed and sensitivity while ... technique Backgrounded Membrane Imaging. ... HORIZON subvisible particle analysis system ...
Breaking Medicine Technology: