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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

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