OTC Asthma Inhaler to Return to Market After Seven Years

The US Food and Drug Administration (FDA) on Wednesday approved Amphastar Pharmaceuticals' Primatene Mist (Epinephrine Inhalation Aerosol Spray) metered-dose inhaler for over-the-counter (OTC) use to treat mild asthma, making it the first OTC asthma inhale the has been off the market seven years ago.

In 2011, Primatene Mist and other asthma inhalers that used ozone-depleting chlorofluorocarbon (CFC) propellants were phased out to comply with the 1989 Montreal Protocol of Substances that Deplete the Ozone Layer and the 1990 Clean Air Act.

Since then, drugmakers have introduced asthma inhalers that use the more environmentally-friendly hydrofluoroalkane (HFA) as a propellant. However, Amphastar has struggled to get a reformulated version of Primatene Mist using HFA on the market for OTC use.

In 2014, FDA rejected Amphastar's first attempt to bring a reformulated version of Primatene Mist to market after its nonprescription Drugs and Pulmonary-Allergy Drugs advisory committees voted against approving the inhaler.

Two years later, FDA rejected another application for Primatene Mist, and the need for clinical trials to improve patient outcomes.

In fact, FDA says that it should be considered that it is a complicated set of issues, that it should be understood that patients with asthma do not rely on it.

As such, FDA has approved Primatene Mist "to provide temporary relief for mild symptoms, intermittent asthma," and only for patients aged 12 and older who have been diagnosed with asthma.

"FDA Commissioner Scott Gottlieb and Center, FDA Commissioner," For the right patient, our analysis of the data, including new information that was developed since the product was previously on the market, for Drug Evaluation and Research Director Janet Woodcock.

Statement, CDER Conversations, Label