Perrigo "Drug Facts" Deferral Requests Include Products With Templates
This article was originally published in The Tan Sheet
Executive Summary
Perrigo has requested a deferral from the OTC labeling final rule's effective date for several drugs that FDA already has provided template "Drug Facts" labels.
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Labeling exemptions
McNeil asks for additional eight months to comply with OTC labeling final rule for 10-count convenience-size vials of Tylenol Extra Strength and PM in July 24 exemption requests. J&J subsidiary notes additional time may be required if FDA demands changes to proposed wrap-around "Drug Facts" label. Meanwhile, Thursday Plantation expects response to application for exemption from font size restrictions on its 2 oz. Pure Tea Tree Oil product by end of August, Australian firm says Aug. 1. Perrigo also submits multiple exemption requests (1see story, p. 3)
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