Pfizer urges delay on Omnitrope NDA

PFE amended its Citizen Petition that requested that FDA deny approval of an application from Sandoz to market Omnitrope, a generic human growth hormone product. PFE called on FDA to defer action on the Sandoz application "until completion of the forthcoming hearings by the agency on follow-on biological products and the preparation of proposed guidelines for the approval of such products." ...