Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) for an abbreviated new drug application (ANDA) of Mirtzapine orally disintegrating tablets (ODTs) of 15 mg and 30 mg, and tentative approval for 45 mg.
According to a release issued by Aurobindo Pharma to the BSE today, the company will be able to sell Mirtazapine ODTs 15 mg and 30 mg immediately and 45 mg tablets after the expiry of 180 days exclusivity period, which is expiring in February 2006.
Mirtazapine is the generic version of Organon's Remeron SolTab, and is prescribed for the treatment of major depressive disorder, the release added.
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