logo
Share SHARE
FONT-SIZE Plus   Neg

Endo Pharma Files Amendment To Its Citizen Petition With FDA - Quick Facts

Endo Pharmaceuticals (ENDP) said it has filed an amendment to its Citizen Petition with the FDA calling on FDA to publicly address numerous concerns raised by Endo and other experts about approval requirements for generic versions of LIDODERM, or lidocaine patch 5%.

The amended Citizen Petition highlights the growing scientific and regulatory support for requiring generic manufacturers to conduct comparative clinical endpoint studies to demonstrate bioequivalence to locally acting topical products like LIDODERM. The amended Citizen Petition also raises several new issues that need to be resolved before FDA approves a generic formulation of LIDODERM.

The amended Citizen Petition asks FDA to address the repeated public statements by scientific experts and FDA officials that pharmacokinetic studies, which measure the level of a drug in the bloodstream, have not yet been validated as a bioequivalence method for locally acting topical drugs like LIDODERM.

The amendment also points out that FDA has not produced any evidence indicating that pharmacokinetic studies are sufficiently sensitive to determine whether a proposed generic product will replicate LIDODERM's clinical effect.

Ivan Gergel, Executive Vice President of R&D and Chief Scientific Officer at Endo, said, "..FDA must publicly address the many unanswered questions from the original petition, as well as the additional concerns raised in this amendment, before taking any formal steps toward the approval of a generic version of LIDODERM."

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Social media app Snapchat has introduced a new location service, Snap Map, that will allow users of the app to see the location of all their friends on a map. The new feature will essentially allow a user to see where his friends are hanging out and what they are up to and also share his own location with friends in real time. The U.S. has suspended all imports of fresh beef from Brazil due to recurring concerns about the safety of the products. The suspension of shipments from Brazil, the fifth largest exporter of beef to the U.S., will remain in place until the Brazilian Ministry of Agriculture takes corrective action, the U.S. Department of Agriculture or USDA said in a statement. The annual Federal stress test was cleared by 34 top banks. The result shows strong capital levels and the ability of large banks to remain capitalized even in stressed situations. The Federal Reserve noted that these banks will be able to lend to households and businesses even at severe recession and throughout the economic cycle.
comments powered by Disqus
Follow RTT