Abbott Files NDA For Sevorane Anesthetic

Abbott Laboratories has filed a New Drug Application in the USA for its new inhalation anesthetic Sevorane (sevoflurane), seeking approval to market the drug for the induction and maintenance of general anesthesia in adult and pediatric patients for both inpatient and outpatient surgery.

Sevoflurane has been available in Japan since 1993, and has already been used in over two million patients. The anesthetic was originally developed by Maruishi Pharmaceutical of Japan, which licenses the drug to Abbott. Elsewhere, sevoflurane has been approved for marketing in Peru, Argentina, Columbia and Mexico, and applications are pending in other Latin American countries and Europe.

Commenting on the application, Clair Callan, vice president of medical and regulatory affairs, hospital products at Abbott, noted that "cost pressures, increases in outpatient surgical procedures and advancements in clinical specialties, like endoscopy, have created the demand for anesthetic agents with rapid induction of anesthesia, greater control during anesthesia and rapid emergence from anesthesia." Abbott believes that Sevoflurane has the characteristics necessary to meet these needs.