Zydus Cadila has received tentative approval from the United States Food & Drug Administration (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 characterized by symptoms of urinary urgency, with or without urge incontinence. It will be manufactured 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.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.
