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 Cetirizine Hydrochloride
Tablets, “over the counter”, (OTC), 5 mg and 10 mg, (Cetirizine HCl).
Cetirizine HCl, which will be marketed as two separate OTC products in
two strengths of 5 mg and 10 mg, is an antihistamine drug, which is used to
treat allergies, hives, and other allergic inflammatory conditions. These
new products are the bioequivalent to Zyrtec Allergy Tablets(R) and Zyrtec
Hives Relief Tablets(R), registered trademarks of Pfizer, Inc.
Daniel H. Movens, Caraco’s Chief Executive Officer, said, “We are
pleased to have the opportunity to market these products as they represent
the first “over-the counter” products to be added to our current portfolio
of prescription products. Zyrtec Allergy(R) has just been approved for the
OTC market and we are pleased to be able to market a generic OTC version as
an alternative. It previously was marketed strictly as a prescription
product under the Zyrtec(R) brand name where it had done over $1.3 billion
in prescription sales. We continue to focus on working towards expanding
our product offering as quickly and effectively as possible. We plan to
market these products to the generic pharmaceutical and OTC market
immediately. This will bring our total product selection to 45 different
products represented by 96 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.