Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Methimazole Tablets USP, 5 mg and 10 mg
Date:9/26/2007

DETROIT, Sept. 26 /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 Methimazole Tablets USP, 5 mg and 10 mg (Methimazole).

Methimazole is indicated in the medical treatment of hyperthyroidism. Caraco's Methimazole is therapeutically equivalent to the FDA reference listed drug (RLD) listed in the Orange Book, Methimazole Tablets USP, 5 mg and 10 mg, respectively. According to IMS Data, for the twelve months ended June 2007, Methimazole had annual sales of approximately $21 million.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to receive this approval from the FDA. This marks the third approval in the last 30 days and the sixth approval this quarter. This is in addition to the two tentative approvals granted by the FDA during the period. One of the main driver's of our growth is to continue to expand and strengthen our product portfolio. This will bring our total product selection to 41 different products represented by 86 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 biology technology :

1. Analyzing Trace-Level Impurities of a Pharmaceutical Intermediate Using an LCQ Deca Ion Trap Mass Spectrometer and the Mass Frontier Software Package
2. Practical Applications of HyperDSC in a Pharmaceutical Laboratory
3. World Class Life Science and Pharmaceutical Companies Leverage DoveBid s Global Reach for Asset Management and Disposition
4. Deltanoid Pharmaceuticals begins phase II osteoporosis study
5. Doing the pharmaceutical tango
6. Want to squeeze U.S. pharmaceutical companies? Be careful what you ask for
7. The Coming of Biotech Generic Pharmaceuticals
8. Knowledge Management: The Key to Success for Life Sciences and Pharmaceutical Companies
9. Speaker announces business members of IT Task Force
10. Doyle announces technology tax credits for Berbee
11. Doyle announces new energy, global warming policies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... ... ... at the University of Athens say they have evidence that the variety of different ... lead to one good one. Surviving Mesothelioma has just posted an article on the ... 98 mesothelioma patients who got a second kind of drug therapy after ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... ... U.S. Food and Drug Administration (FDA) has granted the company’s orphan drug designation ... company’s second orphan drug designation granted by the FDA. , Spinocerebellar ataxia ...
(Date:5/24/2016)... ... , ... Last week, Callan Capital, an integrated wealth management firm specializing in ... San Diego Life Science event at the Estancia La Jolla Resort and Spa. , ... speakers Dr. Rich Heyman, former CEO of Aragon and Seragon, and Faheem Hasnain, former ...
(Date:5/23/2016)... ... 23, 2016 , ... PrecisionAg® Media has released its latest ... The paper outlines the key trends that are creating both opportunities and challenges ... lot of highs and lows as the precision agriculture market has grown and ...
Breaking Biology Technology:
(Date:4/13/2016)... , April 13, 2016  IMPOWER physicians supporting Medicaid ... setting a new clinical standard in telehealth thanks to ... leveraging the higi platform, IMPOWER patients can routinely track ... and body mass index, and, when they opt in, ... convenient visit to a local retail location at no ...
(Date:3/22/2016)... PUNE, India , March 22, 2016 ... new market research report "Electronic Sensors Market for ... Fingerprint, Proximity, & Others), Application (Communication & ... and Geography - Global Forecast to 2022", ... consumer industry is expected to reach USD ...
(Date:3/15/2016)... , March 15, 2016 --> ... published by Transparency Market Research "Digital Door Lock Systems Market ... 2015 - 2023," the global digital door lock systems market ... in 2014 and is forecast to grow at a CAGR ... micro, small and medium enterprises (MSMEs) across the world and ...
Breaking Biology News(10 mins):