See more news releases in: Biotechnology, Health Care & Hospitals, Medical Pharmaceuticals, New Products & Services, FDA Approval
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Methimazole Tablets USP, 5 mg and 10 mg
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.
Back to top
Custom Packages
Browse our custom packages or build your own to meet your unique communications needs.
PR Newswire Membership
Fill out a PR Newswire membership form or contact us at (888) 776-0942.
Learn about PR Newswire services
Request more information about PR Newswire products and services or call us at (888) 776-0942.
Featured Video
More in These Categories
Journalists and Bloggers
![]()
Visit PR Newswire for Journalists for releases, photos, ProfNet experts, and customized feeds just for Media.
View and download archived video content distributed by MultiVu on The Digital Center.
Free Investing Newsletter from Investor Uprising!
Learn to navigate the world's financial system and profit from leading companies.
Register for Investor Uprising, the people's investment site, for a free weekly newsletter, information, education and premium research including our latest IU Confidential Report - "All The Glitters: The Ultimate Gold Report".
