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Desmopressin Battle: Ferring Asks FDA To Reject Serenity's Nocturia Drug

 
• By Sue Sutter

Serenity's SER120 should be held to the same efficacy standards as Ferring's Nocdurna, which the agency has declined to approve three times, citizen petition says.

Ferring Pharmaceuticals Inc. has turned to the US FDA's citizen petition process to keep Serenity Pharmaceuticals LLC from being the first to market with a desmopressin drug approved for nocturia.

In a Nov. 22 petition, Ferring requests FDA refrain from approving Serenity's new drug application (NDA) for SER120, a desmopressin nasal spray partnered with Allergan PLC

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