The US Food and Drug Administration (FDA) has approved the first generic version of Effexor XR extended release capsules (venlafaxine hydrochloride). The antidepressant, used for depression treatment, will be manufactured by Teva Pharmaceuticals, based in North Wales, PA.
Effexor XR is used for the treatment of major depressive disorder. Symptoms include feelings of sadness, loss of interest in pleasurable activities, and hopelessness. It is also indicated for the treatment of generalized anxiety, social anxiety and panic disorders.
“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, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research.
“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.”
Venlafaxine hydrochloride extended-release capsules will be available as 37.5 milligram, 75 milligram, and 150 milligram capsules.
Prescribing information for the generic version of Effexor XR may differ from that of the brand name because of patents held by Wyeth Pharmaceuticals, the FDA said. But the same safety warnings will apply.
Generic Effexor XR's label will include a warning that antidepressants may raise the risk of suicidal thoughts or tendencies among some children, teens and young adults within the first few months of treatment, the agency said. The warning will also note that depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions.
The shipments of the generic Effexor XR are expected to start on July 1st as per the terms of a 2006 agreement with Wyeth.
“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, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research.
“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.”
Venlafaxine hydrochloride extended-release capsules will be available as 37.5 milligram, 75 milligram, and 150 milligram capsules.
Prescribing information for the generic version of Effexor XR may differ from that of the brand name because of patents held by Wyeth Pharmaceuticals, the FDA said. But the same safety warnings will apply.
Generic Effexor XR's label will include a warning that antidepressants may raise the risk of suicidal thoughts or tendencies among some children, teens and young adults within the first few months of treatment, the agency said. The warning will also note that depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions.
The shipments of the generic Effexor XR are expected to start on July 1st as per the terms of a 2006 agreement with Wyeth.
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