Teva announces approval of Mirtazapine
The US Food and Drug Administration (FDA) has granted final approval for Teva Pharmaceutical Industries's Mirtazapine Tablets, 15 milligrams and 30 milligrams. Shipment will begin immediately.
Mirtazapine tablets are the first AB-rated generic version of Organon's Remeron, and are indicated for the use as monotherapy for the treatment of depression. As the first company to file an ANDA with a paragraph IV patent certification, Teva has been awarded 180 days marketing exclusivity. Annual sales in the US for Remeron are approximately $354 million.
Teva Pharmaceutical Industries, headquartered in Israel, is among the top 35 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80 percent of Teva's sales are in North America and Europe. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. — (menareport.com)
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