For J&J OTC Sales, Tylenol Arthritis Label Approval Could Bring Relief Closer
This article was originally published in The Tan Sheet
FDA’s approval positions J&J/McNeil to return Tylenol 8HR Arthritis to the market with new packaging to interest consumers while also sustaining their connection with the iconic brand. The latest label design for the product features different color schemes and text fonts than the most recent previous changes.
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McNeil scaled up its manufacturing “volume and complexity substantially” following J&J’s acquisition of Pfizer’s consumer business in 2006, says McNeil Consumer VP Shane Freedman. “Just a few years later, we had the recalls” that led eventually to a consent decree with FDA,” he says.
Johnson & Johnson CEO Alex Gorsky says he expects 75% of OTC products previously recalled to be back on the market in 2013, and the firm will begin prioritizing marketing efforts once a consistent supply of products is restored. The McNeil Fort Washington facility will remain offline another year.
Failing to qualify suppliers “one of the more common citations” FDA inspectors find at supplement facilities, says ORA deputy director Michael Dutcher. “If you're not sort of reconfirming once in a while it could lead to a problem with your products that you weren't even expecting.”