DETROIT, June 30 MI-CaracoPharm-FDA
DETROIT, June 30 /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 Applications (ANDAs) for Amitriptyline Hydrochloride USP Tablets, 10
mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.
Amitriptyline Hydrochloride is an antidepressant. Its use is indicated to
treat symptoms of depression. According to IMS Data, for the twelve months
ended March, 2008, Amitriptyline Hydrochloride USP Tablets had annual generic
sales of approximately $16 million. It is marketed under the brand name of
Elavil(R), a registered trademark of AstraZeneca.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased
to gain these approvals from the FDA. Our focus continues to be working
towards expanding our product portfolio effectively, including products that
are already available generically in the market that potentially can offer
additional measurable value."
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.
