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.
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