FDA's warning May 12 to consumers not to swallow Benadryl Extra Strength Itch Stopping Gel is another blow to manufacturer Johnson & Johnson's reputation following multiple high-profile recalls by the firm's subsidiary McNeil Consumer Healthcare (1"The Tan Sheet" May 10, 2010). The agency warned the public not to consume the gel when it discovered 121 adverse event reports linked to cases of mistaken ingestion of the gel - seven of which were serious - between 2001 and 2009. FDA said consumers confused the topical product with Benadryl oral liquid products, which have similar consistency and packaging. The agency did not ask J&J to stop using the umbrella name for the product as it recently asked Novartis to rebrand a Maalox line extension that was not an antacid (2"The Tan Sheet" Feb. 22, 2010). However, J&J has added "For Skin Use Only" to the product labeling and launched consumer studies to identify other causes of confusion
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While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
