Replies to post #303332 on Amarin Corp Plc (AMRN)

[louieblouie]

thats really screwed up. Stupid FDA should have gone forward with the rule if they are truly concerned about safety. Clearly this shows they are not.

[bigkahuna2006]

"It runs contrary to the goals of the generic approval process, which requires generic medicines to have the same label as the reference listed drug," Gottlieb and Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research, said.

However, Gottlieb and Woodcock acknowledged that some generic drug labels need updates. As such, the officials announced that FDA will launch a new program for updating the labels on certain generic cancer drugs. The officials also said FDA is working with Congress on the agency's potential need for new authority or resources to address outdated generic drug labels."

[Bolio98]

FDA was not involved in the GSK Teva case and they would not be involved in the AMRN vs generic case either.