среда, 26 октября 2011 г.

Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval To Market Generic Mobic(R)

Caraco Pharmaceutical
Laboratories, Ltd., (Amex: CPD) announced today that the U.S. Food and Drug
Administration (FDA) has granted final approval for the Company's
Abbreviated New Drug Application (ANDA) for Meloxicam Tablets.


Caraco's Meloxicam Tablets is the generic equivalent of Boehringer
Ingelheim's Mobic(R) a nonsteroidal anti-inflammatory drug, (NSAID) which
is indicated for the relief of the signs and symptoms of osteoarthritis.
Caraco has two strengths available, 7.5 mg and 15 mg tablets.


Daniel H. Movens, Caraco's Chief Executive Officer said, "We are
pleased to gain this approval and have another product to market, adding
value to our portfolio of products we market in the U.S. It will complement
our current product mix by adding another nonsteroidal anti-inflammatory
product to our line. We plan to launch this product to the market
immediately. This approval brings our total marketed product selection to
22 different products represented by 47 strengths."


Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,
manufactures and distributes generic and private-label prescription
pharmaceuticals to the nation's 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: information is of a preliminary nature and may be subject to
adjustment, not obtaining or delays in obtaining FDA approval for new
products, governmental restrictions on the sale of certain products,
dependence on key personnel, 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,
integrity and reliability of the Corporation's data, lack of success of
attaining full compliance with regard to regulatory and cGMP compliance,
experiencing difficulty in managing our recent rapid growth and anticipated
future growth, dependence on limited customer base, occasional credits to
certain customers reflecting price reductions on products previously sold
to them and still available as shelf- stock, possibility of an incorrect
estimate of charge-backs and the impact of such an incorrect estimate on
net sales, gross profit and net income, dependence on few products
generating majority of sales, product liability claims for which the
Company may be inadequately insured, subjectivity in judgment of management in applying certain significant accounting policies derived based on historical experience, terms of contracts, our observations of trends of
industry, information received from our customers and other sources, to
estimate revenues, accounts receivable allowances including chargebacks,
rebates, income taxes, values of assets and inventories, litigation
involving claims of patent infringement, litigation involving claims for
royalties relating to a prior contract for one product and other risks
identified in this report and identified from time to time in our reports
and registration statements filed with the Securities and Exchange
Commission. 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.


Caraco Pharmaceutical Laboratories, Ltd.

Caraco Pharmaceutical Laboratories

Комментариев нет:

Отправить комментарий