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FDA Advisory Committee Is Sign Of Grim Progress For Ferring’s Nocdurna

 
• By Sarah Karlin-Smith

Ferring’s nocturia treatment seems headed for another rejection, but a chance to make its case at an advisory panel can be seen as a win for company’s 505(b)(2) desmopressin application.

After two cycles of review, two “complete response” letters and a dispute resolution meeting that ended with FDA still negative on the risk-benefit balance of Ferring Pharmaceuticals Inc.’s nocturia treatment desmopressin, the agency threw the company an unusual and perhaps positive bone – an advisory committee review Jan. 12.

While the Endocrinologic and Metabolic Drugs Advisory Committee meeting seems unlikely to go Ferring’s way, FDA’s decision to hear the opinions of outside experts instead of sending the company directly...

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