Product – Pexeva

Pexeva^Ž(paroxetine mesylate)

Pexeva^® is a selective serotonin re-uptake inhibitor (SSRI) antidepressant indicated for major depressive disorder, panic disorder, obsessive compulsive disorder and generalized anxiety disorder. Pexeva^® is part of the psychiatry products franchise of JDS Pharmaceuticals, LLC, which was acquired by Noven in August 2007, and it is marketed in the U.S. by the JDS sales force. It is one of only two remaining patented brands without a generic equivalent in the SSRI market. Pexeva^® is subject to a composition of matter patent that extends to 2017 and other patents extending to 2022.

For additional information, visit www.pexeva.com.

For full prescribing information on Pexeva^®, click here.

For patient, physician and pharmacist inquiries
regarding Pexeva^®, please contact:

Kendle International, Inc.
441 Vine Street
Suite 1200
Cincinnati, Ohio 45202
Attn: Safety Department
Ph: 800-455-8070

Important Safety Information

Suicidal thoughts or behavior and antidepressant drugs Short-term studies have shown that antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults. When deciding to use PEXEVA® or any other antidepressant in these age groups, people must balance the risk with the potential benefit to the patient. Short-term studies did not show an increased risk of suicidality with antidepressants compared to placebo in adults beyond age 24; the risk decreased in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored by their doctor and watched closely to see if their condition worsens, if they have suicidal thoughts or behavior or if they exhibit any unusual changes in behavior. Families and caregivers need to understand that they should watch the patient closely and tell the doctor if they have any concerns. PEXEVA® is not approved for use in pediatric patients.

The most common side effects that have been reported with PEXEVA® include nausea, dry mouth, constipation, decreased appetite, infection, drowsiness, tremor, sweating, muscle weakness, trouble sleeping, abnormal ejaculation, impotence and other male genital disorders, and female genital disorders.

Please see Important Safety Information, including Black Boxed Warning. Please see accompanying full Prescribing Information including use in Pregnancy. (See WARNINGS-Clinical Worsening and Suicide Risk and Usage in Pregnancy: Teratogenic and Nonteratogenic Effects).