FDA Approves First Generic Venlafaxine Extended-Release Capsules

Yael Waknine

June 29, 2010

June 29, 2010 — The US Food and Drug Administration (FDA) has approved the first generic version of venlafaxine HCl extended-release capsules (Teva Pharmaceuticals, Inc; brand name Effexor XR; Wyeth Pharmaceuticals, Inc) for the treatment of major depressive disorder. The capsules will be available in 37.5-, 75-, and 150-mg strengths.

"The approval of this widely used antidepressant is another example of the FDA's efforts to increase access to safe and effective generic drugs," said Keith Webber, PhD, deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, in an agency news release. "Access to treatments for depression is important because depression can interfere with a person's daily life and routine, which can significantly affect relationships with family and friends."

In addition to depression, brand-name venlafaxine is also indicated for the treatment of generalized anxiety, social anxiety, and panic disorders.

According to the FDA, these and other differences in prescribing information for the 2 formulations are the result of Wyeth's patent and/or exclusivity protection of certain indications and label sections.

Similarities include safety warnings, including a black-box warning regarding the increased risk for suicidal thinking and behavior in children, adolescents, and young adults receiving antidepressants. This risk may be increased in patients with, or a family history of, bipolar disorder or suicidal thoughts/actions.

All patients being treated with venlafaxine should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, particularly during the first few months of therapy and during dose increases or decreases.


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