Company Watch

Caraco gets USFDA nod for Methimazole

Our News Bureau - Mumbai

Caraco Pharmaceutical Laboratories, a subsidiary of Sun Pharma, has announced that the US Food and Drug Administration (FDA) has granted final approval for the company's ANDA for Methimazole Tablets USP in 5 mg and 10 mg doses. Methimazole is indicated in the medical treatment of hyperthyroidism. Caraco's Methimazole is therapeutically equivalent to the FDA reference listed drug (RLD) listed in the Orange Book. According to IMS Data, for the twelve months ended June 2007, Methimazole had annual sales of approximately $21 million.

The company has also received tentative USFDA approval for its ANDA for cetirizine hydrochloride chewable tablets in 5 mg and 10 mg doses (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. Zyrtec Chewable tablets had US sales of approximately $75 million for the 12-month period ended June 30, 2007, according to IMS Data.