FDA Advisory Committee Is Sign Of Grim Progress For Ferring’s <em>Nocdurna</em>

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

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...