Sun Pharma's US subsidiary, Caraco Pharmaceutical Laboratories Ltd. has received final approval from US FDA for the company's Abbreviated New Drug Application (ANDA) for methimazole 5 mg and 10 mg tablets.

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 5 mg and 10 mg tablets, respectively. According to IMS Data, for the twelve months ended June 2007, methimazole had annual sales of approximately $21 million, said the company in a press release.

"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," said, Daniel H. Movens, chief executive officer, Caraco.

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.