Home » FDA Approves Ferring’s Nocdurna NDA, Nixing Two Petitions
FDA Approves Ferring’s Nocdurna NDA, Nixing Two Petitions
Drugs Regulatory Affairs
The FDA approved Ferring Pharmaceuticals’ NDA for Nocdurna (desmopressin), a nocturia treatment, rejecting petitions from Serenity Pharmaceuticals and Avadel requesting that it deny the application.
Avadel petitioned the agency to deny Ferring’s pending NDA unless the company conducted clinical trials that include Phase 3 data and at least two clinical studies for both genders if gender-specific dosage regimens are required.
Serenity, meanwhile, petitioned the FDA to deny the application because Ferring had not demonstrated the drug is safe or clinically beneficial for use in patients with nocturia and said the company’s study design was insufficient to accurately assess the safety risks.