Malcolm Spicer, Managing Editor – US
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Latest From Malcolm Spicer
National Advertising Division recommends Sanofi add "nearly" to claim that Xyzal Allergy 24HR is "as effective at half the size" of J&J's Zyrtec in a TV ad because 3D modeling comparing the products showed Xyzal tablet has 73-mm volume and a Zyrtec tablet's is 145.2 mm. Sanofi's evidence also supported referring to Xyzal's size would not mislead consumers to expect its drug has half the pharmaceutical dosage of Zyrtec.
A report submitted with appropriations legislation negotiated by conference committee and approved by both chambers instructs FDA to report to Congress about its activities and staffing for oversight of supplement manufacturers and marketers. In an indication members are aware of the scope of FDA's responsibilities in the sector, report also asks agency to provide information on work related to "manufacturers and marketers of products claiming to be dietary supplements."
McDaniel Life-Line recalls its Indian Herb supplement after FDA determined it was marketed without an NDA for claims including "blood disorders." For third time in less than a year, John Paul Mitchell Systems brand and other shampoos recalled by manufacturer Bocchi Labs due to potential contamination; other health, beauty and wellness product recalls.
Moberg had been expanding its OTC topical and nutritional supplement portfolio while also continuing trials for Rx ingredients including its MOB-015 formulation of terbinafine indicated for fingernail and toenail fungus. But $155m agreement with two investment groups will complete Moberg's divestment of consumer health brands and make it dedicated to R&D, regulatory matters and business development.
Commissioner Scott Gottlieb announces FDA's plan for policy changes to implement "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years." Plan includes steps to ensure its regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, particularly finalizing NDI notifications guidance and fostering submissions of the notifications.