The Hindu Business Line : USFDA nod for Aurobindo Pharma drug application

AUROBINDO Pharma Ltd, has announced that it has obtained the approval of the United States Food and Drug Administration (USFDA) for its first abbreviated new drug application (ANDA) for Mirtazapine tablets of 7.5mg, 15mg, 30mg and 45mg.

The drug is indicated for treatment of major depressive disorders.

In a press release here on Monday, the company said that the active pharmaceutical ingredient (API) is manufactured at the company's unit-1 and the formulation is manufactured at unit-3.

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