DETROIT, Sept. 26 /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 Methimazole Tablets USP, 5 mg and 10 mg (Methimazole).
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, Methimazole Tablets USP, 5 mg and 10 mg, respectively. According to IMS Data, for the twelve months ended June 2007, Methimazole had annual sales of approximately $21 million.
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 driver's 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."
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
|SOURCE Caraco Pharmaceutical Laboratories, Ltd.|
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