Please login to the form below

Not currently logged in
Email:
Password:

FDA must come to decision on Omnitrope, says judge

Sandoz confident that generic version of biotech drug will gain regulatory approval

The US Food and Drug Administration (FDA) must decide whether to approve or reject an application by Novartis' generics unit, Sandoz, to market a drug to treat growth disorders, a federal judge has ruled.

In September 2005, Sandoz filed a suit against the FDA alleging that it violated federal law by failing to come to a decision on its marketing application for Omnitrope, a version of human growth hormone.

The issue reflects the current grey area surrounding approvals of generic versions of biotechnology drugs. With patents on the oldest biotech drugs beginning to expire, the generics industry is exerting pressure on the US government to formulate clear legislation on the approval process for generic versions.

While the FDA said it did not identify any deficiencies in the Omnitrope application, it said it had not been able to come to a final decision due to uncertainty regarding scientific and legal issues.

Ricardo Urbina, a judge in the US District Court for the District of Columbia said in an opinion that the FDA is required to meet a statutory deadline in its decisions on whether to approve drugs. He wrote that the agency had ìidentified no compelling reason for its court to excuse its delayî.

Sandoz could have the option of a hearing before the Secretary of Health and Human Services.

In a statement, Sandoz said it ìlooks forward to FDA's decision and expects a positive outcomeî.

Sandoz is currently waiting for the European Commission to grant final marketing authorisation before Omnitrope can be sold in Europe.

30th September 2008

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Market Access Transformation

Market Access Transformation (MAT), founded by industry veterans Baiju Aurora and Paul Howard, specializes in developing cutting edge technologies that...

Latest intelligence

Asit Parikh
Gut instincts lead Takeda to GI pipeline success
Takeda’s Asit Parikh talks about a game changer for IBD patients and the company’s long-term strategy for gene and cell therapy...
Covid-19 drives change in long-term conditions management
Paul Midgley and Oli Hudson, of Wilmington Healthcare, explore how patients are being empowered to manage their conditions at home...
The importance of health literacy in patient recruitment materials
Have you ever read something that instantly made you want to read on? Or have you begun to read something, and eventually given up because it didn’t resonate with you?...

Infographics