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EU Approval Delay for Janssen’s Spravato?

Third-Party Intervention Raises EU Approval Timing Question

 
• By Alexandra Shimmings and Vibha Sharma

The EMA has received written interventions from third parties relating to its CHMP opinion that the controversial antidepressant should receive EU approval.

Question mark
• Source: Shutterstock

Something seems afoot with the EU approval of Janssen Pharmaceutical Cos.’s controversial new drug for treatment-resistant depression Spravato (esketamine).

The European Medicines Agency has received “written interventions” from third parties relating to the agency’s October recommendation that the drug...

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