 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.
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