Caraco Pharmaceutical LaboratoriesÂ Announces Tentative FDA Approval for Generic Zyrtec Chewable
DETROIT, Oct. 5 -- Caraco Pharmaceutical Laboratories, Ltd.,Â announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Chewable Tablets, 5 mg and 10 mg (Cetirizine HCl Chewable). Final approval to market this product is anticipated subsequent to the expiry of patent protection on December 25, 2007.
Cetirizine HCl Chewable is indicated for the relief of symptoms associated with seasonal allergic rhinitis due to allergens in adults and children 2 years of age and older; perennial allergic rhinitis in adults and children 6 months of age and older; and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. This tentative approval is the bioequivalent to Zyrtec Chewable(R), a registered trademark of Pfizer, Inc. Zyrtec Chewable(R) tablets had U.S. sales of approximately $75 million for the 12-month period ended June 30, 2007, according to IMS Data.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this tentative approval and look forward to the expiration date of the patent on December 25, 2007, which will allow Caraco to market the product. We feel that Cetirizine HCl Chewable complements our previously announced FDA tentative approval of Cetirizine Hydrochloride Immediate Release Tablets, 5 mg and 10 mg, and both products will be positive additions to our portfolio by expanding our product offerings."
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.