14th February 2022

Celix Pharma is pleased to announce its partners’ approval of their Marketing Authorisation (MA) for Fesoterodine fumarate 4mg and 8mg prolonged-release tablets.  

Fesoterodine fumarate is indicated in adults for treatment of the symptoms associated with overactive bladder, a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination. Fesoterodine belongs to a class of medications called antimuscarinics, which work by relaxing the bladder muscles (1). 

“Fesoterodine is an important product in our portfolio with a commercial launch scheduled for Qtr 2 this year, post expiry of the relevant patents, launching first in Celix livery under partners MA, and switching to Celix MA post launch” – Subir Kohli, Co-founder & CEO. 

Commenting on the approval, Shantreddy, Co-founder & COO states “As a prolonged-released tablet, Fesoterodine is a challenging development and we are pleased to have successfully navigated all hurdles to obtain this MA”.     

(1) Source: MedlinePlus (https://medlineplus.gov/druginfo/meds/a609021.html/)