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FDA Approves Mirtazapine, Generic Form of Remeron

DETROIT, April 23 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (Amex: CPD - News) has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Mirtazapine, a generic form of Organon's Remeron, Jitendra N. Doshi, Chief Executive Officer, announced today.

Mirtazapine tablets are indicated for the treatment of major depressive disorders and have a U.S. market potential of approximately $250 million.

The Company has received approval for a unique additional strength of 7.5 mg for the product, apart from regular 15, 30 & 45 mg strengths. The product will be launched shortly.

Mr. Doshi added that the formulary of total products has increased to 18, with 35 strengths in 82 pack sizes. The Company now has three drugs pending FDA approval.

Source: Caraco Pharmaceutical Laboratories, Ltd.

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