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Merry Christmas? Four US FDA approvals and a CRL

 
• By Mandy Jackson

The US FDA took action on five new drug and biologic license applications (NDAs and BLAs) during the two days before Christmas, approving four products or label updates and rejecting one combination therapy.

The US FDA took action on five new drug and biologic license applications (NDAs and BLAs) during the two days before Christmas, approving four products or label updates and rejecting one combination therapy.

Actavis won one and lost one as the FDA approved its Alzheimer's combination drug Namzaric (memantine/donepezil) that was developed with Adamas Pharmaceuticals, but rejected the fixed-dose

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