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FDA Rejects J&J Petition, OKs Duragesic Generics

Law360 (January 31, 2005, 12:00 AM EST) -- The U.S. Food and Drug Administration has rejected petitions to block or delay the approval of generic versions of the Duragesic pain relief patch made by Johnson & Johnson.

Generic drug makers Mylan Laboratories Inc. and Noven Pharmaceuticals received approval for their generic version of Duragesic on Friday.

“The agency's approval is expected to provide patients with access to a lower cost alternative of this pain management system. At the same time that FDA approved Mylan's generic product, it acted on several citizens' petitions requesting that...
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