FDA APPROVES TEVA'S MIRTAZAPINE ORALLY DISINTEGRATING

Teva Pharmaceutical has received final approval from the FDA to market mirtazapine orally disintegrating tablets in 15-, 30- and 45-mg dosage strengths. Mirtazapine tablets are the AB-rated generic equivalent of Organon's Remeron SolTabs, which are indicated for the treatment of major depressive disorder. As one of the first companies to file a Paragraph IV certification for the 45-mg tablet, Teva stated that it expects to share 180-day marketing exclusivity for this strength. The brand product generated approximately $100 million in U.S. sales in 2004, Teva said.