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Biovail receives FDA approval for depression medication

The FDA has given its approval for Biovail Corporation to market its orally disintegrating tablet formulation of citalopram hydrobromide for the treatment of depression.

The novel formulation of citalopram hydrobromide (HBr) may offer physicians a new dosing option with potential benefits and prescribing flexibility that may be advantageous when addressing the needs of certain patients. The product will be available in 10mg, 20mg and 40mg tablets by prescription only.

Patients may benefit from the convenience of the orally dissolving tablet, particularly those who have difficulty swallowing tablets, or those who may not always have access to water.

A study of the American population concluded that nearly 40% of adults have experienced problems with swallowing tablets, and a significant proportion of those fail to comply properly with their prescribed and ongoing dosage.

Statistics from the World Health Organization show that each year, 9.5% of the American population, or about 18.8 million adults, suffer from a depressive illness.