FDA extends ulipristal acetate NDA review period

…of both the pharmacokinetics and pharmacodynamics of the proposed biosimilar and Neulasta. In December 2016, Gedeon Richter withdrew its marketing authorisation application following an indication that the data provided was not sufficient for a positive benefit risk assessment.

Sign up now to open the entire news item.

You are allowed to open only one news item from PMR websites.
  • 1E-mail
    (to send requested information)
  • 2Brief profile
    (required for new e-mails only)

 required fields

You must accept PMR’s Privacy Policy.