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FDA denies application for Tresiba and Ryzodeg

The FDAhas decided not to grant approval to the latest insulin products form Novo Nordisk and has called for additional studies of the drugs.

Foto: Novo Nordisk/PR

Failed!

That was the overall message from the FDA in a complete response letter to the Danish pharma giant Novo Nordisk. The letter comes in response to Novo’s application for approval of the company’s new long-acting insulin Tresiba and the combination drug Ryzodeg for the US market. The letter informs that Novo Nordisk can only gain approval by carrying out additional clinical testing of the drugs to establish cardiovascular safety.

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