Lupin gets tentative USFDA nod for generic version of Mirabegron ER tablets

The approval by the US Food and Drug Administration (USFDA) is for a generic version of Mirabegron ER tablets of strengths 25 mg and 50 mg, Lupin said in a statement.

New Delhi: Drug maker Lupin Thursday said it has received tentative approval from the US health regulator for a generic version of Mirabegron Extended Release (ER) tablets of Astellas Pharma Global Development Inc used to treat overactive bladder.

The approval by the US Food and Drug Administration (USFDA) is for a generic version of Mirabegron ER tablets of strengths 25 mg and 50 mg, Lupin said in a statement.

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Citing IMS MAT March 2019 data, Lupin said Mirabegron ER Tablets, 25 mg and 50 mg, had annual sales of approximately USD 1,501.6 mn (about Rs 10,500 crore) in the US.

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