Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Topamax(R) Tablets
April 02 2009 - 10:03AM
PR Newswire (US)
DETROIT, April 2 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical
Laboratories, Ltd. (NYSE AMEX: CPD) has launched Topiramate tablets
on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma),
immediately following Sun Pharma's recently received approval from
the US Food and Drug Administration (FDA) for its Abbreviated New
Drug Application (ANDA) for generic Topamax(R) tablets. Topiramate
tablets are used as initial monotherapy in patients 10 years of age
and older with partial onset seizures, or primary generalized
tonic-clonic seizures. Topiramate tablets are indicated as
adjunctive therapy for adults and pediatric patients ages 2-16
years with partial onset seizures, or primary generalized
tonic-clonic seizures, and in patients 2 years of age and older
with seizures associated with Lennox-Gastaut syndrome. These
generic versions of Topamax 25 mg, 50 mg, 100 mg, and 200 mg
tablets are bioequivalent to Topamax(R) which is a registered
trademark of Ortho McNeil Janssen Pharmaceuticals, Inc. According
to IMS Data, these strengths of Topiramate had US sales of
approximately $2.3 billion 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 by launching Topiramate tablets
immediately to the marketplace. We continue to focus on working
towards expanding our product offering both as a marketing partner
and through our own development pipeline of products as quickly and
effectively as possible." 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
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