Zydus Cadila has received final approval from the US health regulator to market capsules used in treating overactive bladder with symptoms such as urinary frequency.
The company has received approval from the US Food and Drug Administration (USFDA) to market the fesoterodine fumarate extended release capsules in strengths of 4 mg and 8 mg, the drug firm said in a BSE filing today.
Zydus Cadila will manufacture the drug at the group’s formulations manufacturing facility in Moraiya, Ahmedabad.
Quoting IMS sales data of August 2017, sales of fesoterodine fumarate extended release capsules were estimated at $195.5 million.
Zydus Cadila said it has more than 160 approvals and has so far filed over 300 Abbreviated New Drug Applications (ANDAs) since it had commenced filings in 2003-04.
Shares of the company’s listed entity Cadila Healthcare were trading 1.50 per cent higher at Rs 500.20 per scrip on the BSE.