Biovail Corporation has announced that the Food and Drug Administration (FDA) has accepted for review (effective date June 13, 2004) Biovail's submission of a New Drug Application (NDA) for a novel dosage format of citalopram for the treatment of depression. The application was submitted under the provisions of Section 505(b)(2) of the Food, Drug and Cosmetic Act.
Biovail believes that its novel formulation of citalopram, subject to FDA approval, may offer physicians a new dosing option with potential advantages and prescribing flexibility that may be advantageous when addressing the needs of certain patients.
Citalopram competes in the US$13.8-billion anti-depressant market, which was characterized by year-over-year growth of 10 per cent in 2003. Citalopram generated more than US$1 billion in the U.S. market for the 12 months ended March 31, 2003.