CHPA supports keeping OTC bronchodilators in the OTC Monograph

WASHINGTON — The Consumer Healthcare Products Association earlier this week voiced support for keeping over-the-counter bronchodilators in the OTC Monograph during a recent meeting of the Food and Drug Administration’s Nonprescription Drugs Advisory Committee. 

During the meeting, the committee discussed whether bronchodilators administered by hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma (shortness of breath, tightness of chest and wheezing) should be removed from the monograph. Specific drugs discussed included epinephrine, epinephrine bitartrate and racepinephrine hydrochloride.

CHPA VP regulatory and scientific affairs Barbara Kochanowski spoke on behalf of CHPA, stating that there is no obvious reason to abandon the OTC Monograph as a regulatory path to market.  She noted that the FDA has the ability to amend the monograph to ensure proper performance specifications, such as dosing.

Kochanowski also highlighted that more than 25 million Americans suffer from asthma, and under-use of asthma medicines, particularly among minorities, is an acknowledged challenge.

 

 

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