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Pfizer Petitions FDA To Deny Sandoz Omnitrope NDA; Test Case For Follow-On Biologics

This article was originally published in The Pink Sheet Daily

Executive Summary

Petition indicates that FDA may be close to a decision on Sandoz' 505(b)(2) submission for a follow-on version of human growth hormone. FDA decision will be landmark in development of regulatory pathway for follow-on biologics.

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