Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Roxicodone(R) Tablets
14 Maio 2009 - 11:24AM
PR Newswire (US)
DETROIT, May 14 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical
Laboratories, Ltd. (NYSE Amex: CPD) has recently launched oxycodone
hydrochloride tablets on behalf of Sun Pharmaceutical Industries
Inc., a subsidiary of Sun Pharmaceutical Industries Ltd. (Sun
Pharma), following Sun Pharma's recently received approval from the
US Food and Drug Administration (FDA) for its Abbreviated New Drug
Application (ANDA) for generic Roxicodone(R) tablets. Oxycodone
hydrochloride tablets are an immediate-release oral formulation of
oxycodone hydrochloride indicated for the management of moderate to
severe pain where the use of an opioid analgesic is appropriate.
These generic versions of oxycodone 5 mg, 15 mg, and 30 mg tablets
are therapeutically equivalent to Roxicodone(R) tablets from
Xanodyne Pharmaceuticals Inc. According to IMS Data, these
strengths of oxycodone tablets had US sales of approximately $160
million for the calendar year of 2008. Daniel H. Movens, Caraco's
Chief Executive Officer, said, "We are pleased to add this product
to our portfolio and help address the current shortage in the
marketplace by launching oxycodone tablets. We continue to focus on
working towards expanding our product offerings both as a marketing
partner and through our own development pipeline of products as
quickly and effectively as possible." Roxicodone(R) is a registered
trademark of Xanodyne Pharmaceuticals Inc. 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.
DATASOURCE: Caraco Pharmaceutical Laboratories, Ltd. CONTACT:
Daniel Movens, +1-313-871-8400, or Thomas Versosky,
+1-313-556-4150, both of Caraco Pharmaceutical Web Site:
http://www.caraco.com/
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