FDA Rejects Approval Of Change To Nuvo Anesthetic Cream

Law360, New York (April 18, 2012, 8:49 PM EDT) -- The U.S. Food and Drug Administration has decided against approving changes to the way a Nuvo Research Inc. anesthetic cream is manufactured, the company said Wednesday.

The agency sent a so-called complete response letter to the Galderma Pharma SA unit that holds the worldwide marketing rights to the product, known as Pliaglis, saying it would not approve a supplemental new drug application unless it was provided with more information about the product, according to Nuvo.

Nuvo did not specify what issues the letter cited, saying only...
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