OTC Asthma Inhaler to Return to Market After Seven YearsNovember 9, 2018
Posted 08 November 2018 | By Michael Mezher
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
Categories: Regulatory News