Generic Zyrtec chewable

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On October 5, 2007, Caraco Pharmaceutical Laboratories announced 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 two years of age and older; perennial allergic rhinitis in adults and children six months of age and older; and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children six months of age and older.

This tentative approval is the bioequivalent to Zyrtec Chewable, a registered trademark of Pfizer, Inc. Zyrtec Chewable tablets had U.S. sales of approximately $75 million for the 12-month period ended June 30, 2007, according to IMS Data.

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