Zydus receives tentative approval from the USFDA for Mirabegron Extended-Release Tablets

Zydus receives tentative approval from the USFDA for Mirabegron Extended-Release Tablets Ahmedabad, 2 April, 2019 Zydus Cadila has received the tentative approval from the USFDA to market Mirabegron Extended-Release Tablets (US RLD- Myrbetriq® Extended-Release Tablets), 25 mg and 50 mg. Mirabegron is selective beta 3 -adrenoceptor agonist approved for the treatment of Overactive Bladder (OAB), a chronic condition of the lower urinary tract characteris ed by symptoms of urinary urgency, with or without urge incontinence. It will be manufac tured at the group’s manufacturing facility at SEZ, Ahmedabad. The group now has 259 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04. About Zydus Cadila Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs over 23,000 people worldwide and is dedicated to creating healthier communities globally. Zydus aspires to be a research-based pharmaceutical company by 2020. ***

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