Global Drugs & Biologics Update

Latin America

Anvisa - National Health Surveillance Agency

Anvisa approves novel heart and anesthetic generics

Anvisa has approved two generic products that do not have any competition on the market.  The first is a generic version of remifentanil hydrochloride, an analgesic shown to induce or maintain anesthesia during surgery, including heart surgery, and for the relief of post-operative pain. The substance is also indicated for analgesia and sedation in patients breathing with the help of devices in the Intensive Care Unit (ICU).

The second novel generic is a generic version of propafenone hydrochloride, used for the treatment of heart rhythm disorders as it acts as a stabilizer in the muscle cell membrane of the heart.