FDA relied on proprietary company data, charges Pfizer

Share this article:
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."
Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Legal/Regulatory

Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.