The RAPS store will be under maintenance Saturday, 29 February between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > 11 > OTC Asthma Inhaler to Return to Market After Seven Years

OTC Asthma Inhaler to Return to Market After Seven Years

Posted 08 November 2018 | By Michael Mezher 

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 inhaler the agency has approved since the original Primatene Mist was taken 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 prescription 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, this time requesting the company make labeling and packaging changes and conduct another human factors study to demonstrate patients’ ability to use the product without physician or pharmacist oversight.
In its decision to finally approve Primatene Mist for OTC use, FDA says it had to consider a “complicated set of issues,” including whether patients will understand how to use product correctly and how to ensure that patients with more severe forms of asthma do not rely on it.
As such, FDA has approved Primatene Mist “to provide temporary relief for symptoms of mild, intermittent asthma,” and only for patients ages 12 and older who have been diagnosed with asthma.
“For the right patient, our analysis of the data, including new information that was developed since the product was previously on the market, shows that there are no serious safety concerns when Primatene Mist is used as directed,” FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research Director Janet Woodcock.
Statement, CDER Conversations, Label

Regulatory Focus newsletters

All the biggest regulatory news and happenings.