Pepcid AC Gelcaps Sample Pouch Deferral Granted Without "Drug Facts" Title
This article was originally published in The Tan Sheet
Executive Summary
J&J/Merck's request for a nine-month deferral from complying with the OTC labeling format for sample pouches of the company's H2 antagonist Pepcid AC Gelcaps has been granted.
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J&J/Merck's request for a nine-month deferral from complying with the OTC labeling format for sample pouches of the company's H2 antagonist Pepcid AC Gelcaps has been granted. In a March 23 letter notifying J&J/Merck of its decision, FDA observes that the deferral period, which began the same day, should provide the firm time while it "acquires, implements and validates the equipment necessary to produce compliant sample pouches." The agency adds the deferral is approved with the understanding the sample pouches' labeling "reflects all of the text currently approved for use in Pepcid AC Gelcaps labeling, with the exception that inactive ingredients are not listed." As long as the rest of the labeling follows the "Drug Facts" format, J&J/Merck may distribute the sample pouches during the deferral period. However, the company must "remove the 'Drug Facts' and 'Drug Facts (continued)' titles from the labeling because including this information would give the impression that the agency approved 'Drug Facts' labeling that does not contain all of the required information and that is not in the correct format," FDA states. Moreover, the agency asks that if printed materials are distributed with the pouches, J&J/Merck "consider including the inactive ingredients" in the text. The Pepcid AC marketer originally requested FDA exempt sample pouches of the product from the OTC labeling requirements, stating in an Oct. 22 application for exemption that due to their small size, "it is virtually impossible to accommodate the format and some of the content requirements" contained in the rule (1 (Also see "Pepcid AC Gelcaps OTC Labeling Exemptions Sought By J&J/Merck" - Pink Sheet, 1 Nov, 1999.)). J&J/Merck changed the exemption request to a nine-month deferral request based on agency feedback. In granting the deferral, FDA notes the firm's NDA was approved only two months after the labeling rule's effective date, giving the company little time to comply with the new requirements. NDAed products approved more than 30 days after the final rule's March 17, 1999 publication date are required to comply with the reg's provisions immediately. FDA has said guidance on use of the "Drug Facts" format on single-use and convenience products is forthcoming (2 (Also see "OTC Labeling Implementation Date Extended One Year" - Pink Sheet, 14 Feb, 2000.)). |