New Delhi: Drug firm Zydus Cadila said it 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, it said in a BSE filing.
It will manufacture the drug at the group’s formulations manufacturing facility in Moraiya, Ahmedabad.
Quoting IMS sales data of August 2017, Zydus Cadila said sales of fesoterodine fumarate extended-release capsules are estimated at USD 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 commenced filings in 2003-04.