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Re: DewDiligence post# 85759

Tuesday, 11/03/2009 7:58:01 PM

Tuesday, November 03, 2009 7:58:01 PM

Post# of 257253
"If Bill Marth’s comments are taken at face value, one might infer that the FDA is considering approving Teva’s generic as a non-substitutable “branded” product—as though Teva’s application had been reviewed by the FDA under the 505b2 NDA pathway rather than the 505j ANDA pathway.

Not sure I understand this argument. It implies that applications filed under one approval pathway can somehow 'drift' off into another pathway... with no statements to that effect from either the company nor the FDA? You surely know more than I about the various routes through the maze, but to my knowledge this would be an FDA first.

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