Enzo Challenges Bioequivalence Standard

Law360, New York (December 19, 2006, 12:00 AM EST) -- Enzo Pharmaceutical Holdings Inc. has urged U.S. regulators not to rely on a newly proposed standard for determining whether proposed generic substitutes for Endo’s Lidoderm topical pain patch meet the requirements for bioequivalence with the brand-name Lidoderm treatment.

In a Citizen Petition to the U.S. Food and Drug Administration submitted Monday, Endo claimed that the FDA had proposed a new and ineffective standard based on levels of lidocaine in the blood to ascertain the bioequivalence of generic substitutes to Lidoderm. Lidocaine is the active ingredient in...
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