An FDA First Adds To Rock Creek’s Regulatory Adventures
This article was originally published in The Tan Sheet
FDA “for the first time” notified tobacco retailers about products found to be not substantially equivalent for sale, with each of the 16 warnings identifying Rock Creek’s Ariva and Stonewall Jackson nicotine lozenges. The firm continues turning its operations to drug development after FDA rejected a NDI notification.
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Rock Creek Pharmaceuticals faces investor and consumer class-action complaints on top of ending sales of its nutritionals following an FDA warning. Moreover, the company name is known more in connection with federal officials’ investigation of the former governor of Virginia than for its products.
Pharmacist groups’ representatives, in meeting with FDA officials, reiterate argument for greater role in access to OTCs through “additional conditions for nonprescription use.” Group not at meeting, American Society of Health-System Pharmacists, suggests “intermediate approach to nonprescription status.”
PhRMA captures tone of its comments saying “proposed rule might play an important role” in making more drugs available OTC. AAM also references gauntlet, saying proposed pathway “would, in theory, broaden the types of nonprescription drugs available to consumers.” CHPA discusses same concerns as well as additional questions for FDA.