FDA approves Caraco's generic Tapazole
DETROIT, Mich. The Food and Drug Administration has granted final approval for Caraco Pharmaceuticals application for the generic version of King Pharmaceuticals’ Tapazole, methimazole, in 5 mg and 10 mg strengths.
Daniel H. Movens, Caraco’s Chief Executive Officer, said, “We are pleased to receive this approval from the FDA. This marks the third approval in the last 30 days and the sixth approval this quarter. This is in addition to the two tentative approvals granted by the FDA during the period. One of the main drivers of our growth is to continue to expand and strengthen our product portfolio. This will bring our total product selection to 41 different products represented by 86 various strengths.”
Methimazole is used for treatment of hyperthyroidism. According to IMS Data, for the twelve months ended June 2007, methimazole had annual sales of approximately $21 million.