FDA defers decision on Omnitrope application

Novartis company Sandoz has received notice from the US FDA that it is unable to reach a decision on whether to approve an application for the marketing of the recombinant DNA human growth hormone Omnitrope.

According to the FDA letter issued to Sandoz, the agency has completed its review of Omnitrope and did not identify any deficiencies in the application, but 'uncertainty regarding scientific and legal issues' meant it had been unable to reach a final decision on the application.

'We appreciate the constructive consultations held with the agency, and believe we have submitted complete and thorough data to support marketing approval for Omnitrope,' said Dr Alexander Berghout, head of clinical development and regulatory affairs, biopharmaceuticals, Sandoz. 'We believe it is important for patients and healthcare providers that cost-effective follow-on biologics like Omnitrope become available as safe and effective therapeutic alternatives.'

Sandoz acknowledges that the approval of most follow-on biologics in the US will require new legislation to ensure that the FDA has the authority to fulfil its mission of ensuring the safety and efficacy of every approved medicine. The company supports a transparent public process to help identify an appropriate regulatory pathway for follow-on biologics with an emphasis on ensuring patient safety while protecting the legitimate intellectual property rights of innovator companies.