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BY OUR PHARMA CORRESPONDENT
15 July, 2005: The Israeli generic major Teva Pharmaceutical Industries has been granted final approval for the Abbreviate New Drug Application (ANDA) for 15 mg, 30 mg and 45 mg mirtazapine orally disintegrating tablets, the United States Food &Drugs Administration.
Teva was one of the first companies to file a Paragraph IV certification for the 45 mg dosage strength, and so expects to share the180-days marketing exclusivity for this. The product is a generic version of Organon's Remeron SolTabs, used in the treatment of major depressive disorder, a company release said.
Mirtazapine is a newer antidepressant that exhibits both noradrenergic and serotonergic activity. It is at least as effective as the older antidepressants for treating mild to severe depression. Sedation is the most common side effect. Although agranulocytosis is the most serious side effect, it is rare (approximately one in 1,000) and usually reversible when the medication is stopped. Mirtazapine is relatively safe in overdose.
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