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news.Teva Pharmaceutical Industries has received FDA approval of Venlafaxine HCl ER capsules, the generic version of Wyeth’s antidepressant Effexor XR.
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Venlafaxine is an arylalkanolamine serotonin-norepinephrine reuptake inhibitor (SNRI). It has a similar chemical structure to the opioid derivative tramadol, and has the tertiary amine functional group necessary for mu-opioid receptor recognition (cf. lefetamine), though it is unknown whether it has an opioid agonist effect.
Venlafaxine is effective in treating depression in heroin and other opioid addicts compared to all other conventional anti-depressants.
Effexor XR (venlafaxine HCl) extended-release capsules are indicated for the treatment of depression, generalized anxiety disorder (GAD), social anxiety disorder (SAD), and panic disorder (PD) with or without agoraphobia in adults.
Teva Pharma is expected to start shipping the product on July 1, 2010, as per the terms of the 2006 agreement with Wyeth.
Teva Pharma has been awarded a 180-day period of marketing exclusivity as the first company to file an abbreviated new drug application (ANDA) containing a paragraph IV certification for this product.