Final US FDA approval for Aurobindo''s Mirtazapine oral disintegrating tablets

Aurobindo Pharma Ltd has received final approval from the US Food and Drugs Administration for its abbreviated new drug application (ANDA) for Mirtzapine orally disintegrating tablets (ODT).

Aurobindo can now sell the drug after the expiry of 180-day exclusivity period, which expires in February 2006. The company makes the drug in dosages of 15mg, 30mg, which have been approved and 45mg tablet for which it has a tentative approval. Mirtazapine ODT is the generic version of Organon''s Remeron SolTab(R), indicated for the treatment of major depressive disorder. Annual sales of Mirtazapine ODT tablets in the US are approximately $100 million.

According to the company, many generic manufacturers, despite having approvals for Mirtazapine tablets, find it difficult to develop it in an orally disintegrating tablet form. The product was developed by the company through its own R&D efforts.