Theraflu Disclaimer Exceeds NAD Expectations For Consumer Comprehension
This article was originally published in The Tan Sheet
Novartis’ substantiation fails to support onset of action claims for Theraflu Multi-Symptom Severe Cold in TV, online and print ads, according to a NAD review of a challenge by Pfizer. NAD says a disclaimer in the ads contradicted rather than limited an onset of action claim, and likely was missed by consumers anyway.
You may also be interested in...
FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.
In addition to CBD, Elixicure is formulated with OTC external analgesics monograph ingredients camphor and menthol, But CBD isn't a monograph drug nor approved for use in any pharmaceutical product other than GW Pharmaceutical's Epidiolex.
In addition proposing $28.4m in monograph user fees, agency’s FY 2021 budget justification includes among its legislative initiatives proposing to require "Field Alert Reports" for drug products not marketed under an approved application, such as monograph OTCs.