Zydus Cadila on Tuesday said it has received tentative nod from the US health regulator to market its Mirabegron extended-release tablets. The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market generic Mirabegron extended-release tablets in the strengths of 25 mg and 50 mg, Zydus Cadila said in a statement.
The product will be manufactured at the group’s manufacturing facility at SEZ in Ahmedabad, it added. The tablets are generic version of Myrbetriq extended-release tablets, Zydus Cadila said. The product is used for the treatment of overactive bladder, a chronic condition of the lower urinary tract characterised by symptoms of urinary urgency, with or without urge incontinence, it added.
The group now has 259 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of its filing process, the company said.