Zydus Cadila gets final US FDA approval for Propafenone Hydrochloride ER capsules

Zydus Cadila has received final approval from the USFDA to market Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 mg (US RLD: Rythmol Capsules). Propafenone is known as an anti-arrhythmic drug. It works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 315 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.