FDA Seeks More Info On J&J’s New Pain Drug

Law360, New York (October 4, 2010, 12:25 PM EDT) -- Johnson & Johnson revealed Monday that U.S. health regulators have asked for additional data on the latest formulation of the drug giant’s pain management treatment tapentadol before giving the green light to the product.

The company said it had received a complete response letter from the U.S. Food and Drug Administration for J&J's tapentadol extended-release tablets.

While the FDA has not requested any new clinical studies evaluating the product's efficacy or safety, the agency is requesting data regarding the conversion of the extended-release formulation used in...
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