Mallinckrodt Petitions FDA to Require Evaluations for Inhaled Nitric Oxide Drugs

Mallinckrodt called on the FDA to require coordinated evaluations by CDER and CDRH for all inhaled nitric oxide products. Nitric oxide, with the chemical formula NO, is not to be confused with the anesthetic nitrous oxide (N2O).

The company made the request in a citizen petition, writing that the step would help ensure safety and efficacy. The petition further calls on the FDA to deny any applications for such drugs that do not include key safety features, including: validation of the nitric oxide delivery system with appropriate ventilator types; integrated backup systems to the nitric oxide drugs that can function without main or battery power; and formal training for all aspects of delivery.

The petition also calls on the FDA to rescind receipt of Praxair’s ANDA #2017141, citing potential quality issues raised by the company’s plan to use a nitric oxide drug recently added to an FDA import alert.