Biovail Receives FDA Approval for Citalopram ODT

TORONTO, December 21, 2005 - Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that it has received an Approval Letter from the United States Food and Drug Administration (FDA) for its New Drug Application for an orally disintegrating tablet formulation of citalopram hydrobromide (HBr) for the treatment of depression.

Biovail believes that its novel formulation of citalopram 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.

Biovail's orally disintegrating tablet version of immediate-release citalopram HBr will be available in 10mg, 20mg and 40mg tablets by prescription only. Patients may benefit from the convenience - particularly those who have difficulty swallowing tablets, or those who may not, or do 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.

Biovail is currently considering a number of commercialization options for this product.

Safety Precautions

Patients who take citalopram should see their doctor for regular checks on their progress. Patients and their families should watch out for worsening depression or thoughts of suicide, and for sudden or severe changes in emotion, such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.

About Depression

Statistics from the World Health Organization (WHO) show that each year, 9.5 per cent of the American population, or about 18.8 million adults, suffer from a depressive illness. One of every four women and one in 10 men can expect to be diagnosed with depression during their lifetime. The economic cost for this disorder is high, but the cost in human suffering cannot be estimated. Depressive illnesses often interfere with normal functioning and cause pain and suffering not only to those who have a disorder, but also to those who care about them.

The WHO also predicts that depression will become the leading cause of disability by the year 2020 - second only to ischemic heart disease.

About Citalopram

Citalopram hydrobromide is a highly selective and potent serotonin (5-hydroxytryptamine 5-HT) reuptake inhibitor with minimal effects on the neuronal reuptake of norepinephrine and dopamine. The ability of citalopram to potentiate serotonergic activity in the central nervous system via inhibition of the neuronal reuptake of serotonin is thought to be responsible for its antidepressant action.

Source: Biovail Corporation

Posted: December 2005


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