The US Food and Drug Administration has granted final approval for Teva Pharmaceutical’s ANDA for Mirtazapine Orally Disintegrating Tablets (ODT), 15 mg, 30 mg and 45 mg.

As one of the companies first to file a Paragraph IV certification for the 45 mg tablet, Teva expects to share 180-day marketing exclusivity for this strength. Shipment of this product is expected to begin in the near future, Teva said in a release.

Teva’s Mirtazapine ODT is the AB-rated generic equivalent of Organon’s Remeron SolTabs, a product indicated for the treatment of major depressive disorder.

Total annual sales of this multi-sourced product in the US are approximately $100 million.