FDA
27th February 2014

FDA Panel Recommends Removing EPI Products from OTC Monograph

On Wednesday, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) urged the agency to rescind the inclusion of epinephrine and racepinephrine products delivered via a hand-held rubber bulb nebulizer in the OTC bronchodilator monograph. Advisers noted that the combination product presents safety concerns that only an NDA can address. 

FDA Panel Recommends Removing EPI Products from OTC Monograph

On Wednesday, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) urged the agency to rescind the inclusion of epinephrine and racepinephrine products delivered via a hand-held rubber bulb nebulizer in the OTC bronchodilator monograph. Advisers noted that the combination product presents safety concerns that only an NDA can address.

During the meeting, it was discussed whether bronchodilators administered by hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma (e.g. shortness of breath, tightness of chest, and wheezing) should be removed from the monograph. Specifically, drugs such as epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride were discussed.

More than 25 million Americans suffer from asthma, and under-use of asthma medicines, particularly among minorities, is an acknowledged challenge.

The FDA is not bound by their panel’s decision, but normally abides by their recommendation.

Please click HERE to access the original meeting announcement for this product.

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