Infirst Later Than Expected With Lipid-Format Ibuprofen, But On Time In Business Plan
This article was originally published in The Tan Sheet
The London firm announces Unicough cough/cold product’s launch after reviewing clinical trial results, but holds off on a Flarin ibuprofen launch until completing a trial. “We’re very, very pleased with this, although originally we wanted to be there slightly earlier,” says CEO Manfred Scheske.
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Unlike other OTC deals J&J made since McNeil Consumer Healthcare’s quality-control problems led to widespread recalls and a consent decree with FDA, the firm is not divesting the digestive health lines. Infirst will manufacture and market the products in the U.S. for an undisclosed period before the brands return to McNeil.
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ODS Director Steven Tave says violative manufacturing processes and products remain common not because FDA isn’t enforcing its regulations. “I applaud those who stand behind their products, but can you stand with the same conviction behind every product on the market?” he said at regulatory summit organized by trade groups.