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Title: FDA Approves Oral Solution of Antidepressant Celexa
URL: http://www.pslgroup.com/dg/155A72.htm
Doctor's Guide
January 6, 2000


NEW YORK, NY -- January 6, 2000 -- Forest Laboratories and the Parke-Davis division of Warner Lambert Company announced that the U.S. Food and Drug Administration approved for marketing an oral solution of Celexa(R) (citalopram HBr). Celexa is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of depression.

The oral solution of Celexa is a welcome option for patients who have difficulty swallowing tablets or who prefer liquid medications. The liquid formulation of Celexa is available in a natural peppermint flavor, is sugar free, and -- unlike some other SSRI oral solutions -- contains no alcohol.

Like the tablet formulation, the oral solution of Celexa is a safe and effective first-line medication for the treatment of depression, with a favorable side effect profile and low potential for drug-drug interactions. The oral solution will be available commercially in the first half of 2000.

Celexa oral solution may be especially useful for depressed patients who are elderly -- including those living in long-term care facilities -- since such patients often find liquid formulations easier to take. Elderly patients also are more likely to be taking multiple medications for the treatment of concomitant medical conditions, which increases the risk for potentially dangerous drug-drug interactions.

"It is essential that elderly patients, especially those in long-term care facilities who require antidepressant medication receive treatment that is not just effective, but also safe and well tolerated," according to Steven Roose, MD, professor of psychiatry at Columbia University College of Physicians and Surgeons. "An oral liquid formulation of Celexa will offer added convenience and ease of dosing for elderly patients who have difficulty swallowing pills or tablets."

Introduced in the United States by Forest Laboratories and Parke-Davis in September 1998, Celexa quickly became the fastest-growing SSRI, generating more new prescriptions in its first year than any previously launched product in the antidepressant market. In the U.S., Celexa now has more than a 10 percent share of new prescriptions for antidepressants. Celexa was developed by the Danish pharmaceutical firm, H. Lundbeck A/S, and is the top-selling antidepressant in eight European countries.

Celexa has been proven effective and very well tolerated in clinical trials involving more than 28,000 Celexa-treated patients, as well as by a decade of clinical use during which more than 16 million people in 65 countries have been treated with Celexa.

Among Celexa-treated patients in clinical trials reporting side effects, those most frequently reported were nausea, dry mouth, and sleepiness. As with all SSRIs, Celexa should not be taken together with monoamine oxidase inhibitors and Celexa should not be used in patients with hypersensitivity to citalopram HBr or any other ingredients in Celexa.


Related Links: Forest Laboratories and Warner Lambert Company.

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