Menley & James urges FDA to withdraw reg requiring NDAs for epinephrine MDIs.
This article was originally published in The Tan Sheet
FDA URGED TO WITHDRAW REG REQUIRING NDAs FOR EPINEPHRINE MDIs by Menley & James Laboratories in May 23 comments to the agency. Menley & James maintained that FDA has not provided "a reasonable basis to support the revocation of the generally recognized as safe and effective (GRAS/E) status of pressurized metered dose inhaler aerosol container dosage forms" for epinephrine, epinephrine bitartrate, and racephedrine hydrochloride.
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