DETROIT, Jan. 14 /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 Application (ANDA) for Cetirizine Hydrochloride Chewable Tablets, "over-the-counter", (OTC), 5 mg and 10 mg (Cetirizine HCl Chewable).
Cetirizine HCl Chewable, which will be marketed as two separate OTC products in two strengths, 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 bioequivalent to Children's Zyrtec(R) chewable tablets for allergy relief and Children's Zyrtec(R) for hives relief, registered trademarks of Johnson & Johnson.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this FDA final approval for our second generic "over-the-counter" product to be added to our current portfolio of prescription products. We feel that Cetirizine HCl Chewable complements our previously announced FDA final approval of Cetirizine Hydrochloride Tablets, 5 mg and 10 mg, and both products will be positive additions to our portfolio by expanding our product offerings. Children's Zyrtec(R) chewable tablets for allergy relief have 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, a registered trademark of Pfizer Inc. where it had done over $80 million in prescription sales. We plan to market these products to the generic pharmaceutical and OTC markets immediately."
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.