DETROIT, MI (April 26, 2004) – Caraco Pharmaceutical Laboratories, Ltd. said last week it received approval from the U.S. Food & Drug Administration (FDA) to manufacture and market Mirtazapine, a generic form of Organon’s Remeron. Mirtazapine tablets are indicated for the treatment of major depressive disorders and have a U.S. market potential of approximately $250 million, the company said.Caraco said it received approval for a unique additional strength of 7.5 mg for the product, apart from regular 15, 30 & 45 mg strengths. The product is expected to be launched shortly.Jitendra N. Doshi, Caraco chief executive officer, said that the formulary of total products has increased to 18, with 35 strengths in 82 pack sizes. The company said it now has three drugs pending FDA approval.Detroit-based Caraco Pharmaceutical develops, manufactures and distributes generic and private-label prescription drugs to wholesalers, distributors, drugstore chains, healthcare systems and state and federal agencies.
