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Aurobindo Pharma, Ltd.
U.S. FDA grants approval for Mirtazapine
April 8th, 2006
Aurobindo Pharma, Ltd., announced that the U.S. Food and Drug Administration has granted final approval for Aurobindo's Mirtazapine Orally Disintegrating Tablet (ODT) 45 mg. Last year, Aurobindo received tentative approval for Mirtazapine ODT 45 mg because of 180-day exclusivity by other generic players. Aurobindo already had been granted final approval for Mirtazapine ODT 15 mg and 30 mg. With this final approval, Aurobindo will be able to sell Mirtazapine orally disintegrating tablet (ODT) 45 mg apart from 15 mg, 30 mg. Annual U.S. sales of Mirtazapine ODT tablets are approximately $100 million. The aforesaid tablet is indicated for the treatment...
Source: Law & Health Weekly (2006-04-08)
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