Radius Health receives notification of PDUFA extension for abaloparatide

Radius Health

10 March 2017 - PDUFA goal date extended by standard extension period of three months to 30 June 2017.

Radius Health today announced that the U.S. FDA will require additional time to complete its review of the new drug application  for abaloparatide. 

In a notice received from the FDA last evening, the Prescription Drug User Fee Act date for abaloparatide has been extended to 30 June 2017.

Read Radius Health press release

Michael Wonder

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Michael Wonder

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Medicine , US , Timelines , Submission