Switzerland-based Ferring Pharmaceuticals is launching its NOCDURNA (desmopressin acetate) in the United States, it was reported yesterday.
The product is a sublingual tablet indicated for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken more than two times per night to void. It is claimed to offer a fast-acting, effective treatment that targets the kidneys, the underlying cause of NP.
The sublingual tablet formulation and sex-specific dosing has been indicated to decrease night-time urination by nearly half in adults 18 years and older.
The product received approval from the US Food and Drug Administration (FDA) based on three double-blind placebo-controlled, multi-centre, randomised trials and one open-label extension trial of up to three years in patients 18 years and older.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval