Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma

Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma





Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma

One of our ongoing priorities is making sure consumers have access to the medicines that help keep them healthy. Part of this access includes the availability of safe and effective nonprescription, over-the-counter (OTC) medications that can help empower consumers to address medical conditions.

In order for a product to be approved by the FDA for OTC use, we make sure the product receives a robust scientific review to ensure it can be used safely by patients. While OTC medicines play an important role in public health, with certain OTC medicines, there comes a more complex need to make sure that consumers understand how to best use the product to manage...