Express Pharma

Zydus launches Mirabegron ER tablets in US

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency

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Zydus Lifesciences has launched Mirabegron Extended-Release Tablets, 25 mg in the US market. The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq Extended-Release Tablets). Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India.

Mirabegron Extended-Release Tablets USP 25mg and 50mg had annual sales of $2.42 billion in the US (IQVIA MAT February 2024).

The group now has 393 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

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