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Alkermes Refuse-To-File Reversal: Is It Really Good News For Anyone?

 
• By Kate Rawson

US FDA’s decision to 'un-refuse' ALKS 5461 was made within same review office that was caught up in the Sarepta controversy – albeit in a different division. What does the RTF reversal mean for Alkermes and for the agency?

The US FDA’s decision to reverse a refuse-to-file action on Alkermes PLC’s investigational antidepressant ALKS 5461 is very good news for Alkermes – but it is hard to argue that either the agency or the sponsor comes out of the regulatory kerfuffle looking particularly good.

The decision to refuse-to-file an application is typically based on missing data or facial deficiencies within the submission. In the...

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