INSUBCONTINENT EXCLUSIVE:
NEW DELHI: Drug firm Zydus Cadila 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.
Shares
of Cadila Healthcare, the listed entity of the group, were trading at Rs 345.65 per scrip on BSE, up 0.57 per cent from the previous close
