Aurobindo Pharma Ltd has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Mirtzapine orally disintegrating tablets (ODT) 15 mg, 30 mg and tentative approval for 45 mg tablet.

According to the company release, Aurobindo will be able to sell Mirtazapine orally disintegrating tablets (ODT) 15 mg, 30 mg immediately and 45 mg after the expiry of 180 days exclusivity period, which is expiring in the month of February 2006. Annual US sales of Mirtazapine ODT tablets are approximately USD 100 million.

Mirtazapine ODT is the generic version of Organon's Remeron SolTab and is indicated for the treatment of major depressive disorder.