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FDA OTC Switch Guidance Omits Some Turns As Approval Roadmap, CHPA Says
In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow. CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.
Latest From Consumer
With TheraFlu PowerPods, GSK Brews Market For OTCs From Coffee Makers
GSK takes Theraflu brand from medicine cabinet to kitchen with launch of PowerPods of OTC ingredients delivered through single-serve coffee makers. Introduction of non-coffee pods also is growing, including lemonade, hot ciders, teas and Campbell's Soup pods.
Acne Claims For Cosmetics Leave Blemish On UK Advertising Regs
J&J's Supplement Step With Zarbees Helps Drive A Leap For Consumer Health Growth
Supplement brand being marketed to compete with OTC drugs, including J&J's own brands, in cough and cold and other categories helped J&J overall consumer health sales grow 9.7% to $440m in Q3. Oral care brands showed 3.2% worldwide growth to $384m, benefiting from recent launch of chewable Listerine Ready! Tabs.
Ovarian Cancer Risk Cut 23% With Aspirin Use – Harvard Study
Study analyzed follow-up data on 205,498 women from the Nurses’ Health Study started in 1976 and Nurses’ Health Study II opened in 1989; 1,054 of the women developed ovarian cancer.
ASPREE Results Support FDA Aspirin Label Guidance On Cardiovascular Disease
Data from ASPREE trial with more than 19,000 subjects show five-year-use of low-dose aspirin did not prolong disability-free survival and is associated with a significantly higher rate of hemorrhage and somewhat higher rate of all-cause mortality. Findings in three reports in NEJM track with US FDA's guidance that OTC aspirin marketers include a statement referring to doctors when aspirin package labels include a heart or other image suggesting a CV indication.
Sales of Drug-Spiked Nicotine Could Sink E-Cigarettes' Smoking Cessation Chances
Since Commissioner Gottlieb's appointment, US FDA has challenged END industry more aggressively to eliminate products and advertising targeting children and has said sales to minors could be a focal point of an FDA action to ban all e-cigarette sales. Finding pharmaceutical ingredients in liquid nicotine could make a general ban on e-cigarette sales more likely in addition to imperiling approval for a smoking cessation indication.
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