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Allergan Exits Noctiva Partnership With Serenity Just As FDA Approves Controversial Drug

 
• By Joseph Haas

Just as Noctiva obtains FDA approval as the first drug for nocturia due to nocturnal polyuria, Allergan bails on collaboration signed seven years ago.

Serenity Pharmaceuticals LLC gained FDA approval of its urology drug Noctiva (desmopressin acetate) as the first approved drug therapy for nocturia due to nocturnal polyuria, but it lost Allergan PLC as a marketing partner.

The US FDA approved Noctiva nasal spray March 3, but with a boxed warning and a narrower indication than Milford, Pennsylvania-based Serenity initially sought. The approval followed a less than enthusiastic endorsement by FDA's Bone, Reproductive and Urologic Drugs Advisory Committee Oct. 19 as to whether the drug provided a therapeutic benefit for patients suffering frequent nighttime urination

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