Aurobindo Pharma receives final US FDA approval for Mirtazapine ODT 45mg

Aurobindo Pharma Ltd has announced that US FDA has granted final approval for its 45mg Mirtazapine orally disintegrating tablet (ODT). Mirtazapine ODT is the generic version of Organon''s Remeron SolTab.

Last year, it had received tentative approval for Mirtazapine ODT in 45mg dosage because of the 180-day exclusivity by other generic players. The company had already been granted final approval for Mirtazapine ODT in the dosages of 15mg and 30mg.

With this final approval, Aurobindo Pharma will be able to market Mirtazapine ODT in the three dosages. Annual US sales of Mirtazapine ODT tablets are approximately $100 million for the drug, which is indicated for the treatment of major depressive disorders.

Aurobindo Pharma is among a handful of genericmanufacturers, which has shown its R & D capability by developing this complicated product.