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The Noctiva manufacturer also criticized the subject population in Ferring’s clinical trial, stating that clinical trial enrollment for Noctiva NDAs should be restricted to patients aged 50 or older. Read More
Avadel Specialty Pharmaceuticals called on the FDA to deny approval for certain demopressin acetate treatments for nocturia, including a pending drug application by Ferring, expressing concern over the pharmaceutical company’s clinical trial data and patent certification for the drug. Read More
CDER released a revised Manual of Policies and Procedures on expedited reviews of prior approval supplements for new drug and biologics license applications that involve chemistry, manufacturing and controls changes. Read More