Pfizer’s charge that the FDA relied on proprietary company data on its Genotropin in approving rival Sandoz’ human growth hormone product Omnitrope have been denied by the agency. It said Sandoz had to establish that “Omnitrope is highly similar to Genotropin without reference to proprietary data in Pfizer’s Genotropin NDA.”
From the August 01, 2006 Issue of MM+M - Medical Marketing and Media
