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Posts Tagged ‘U.S. Food and Drug Administration’

HealthDay (6/29, http://tinyurl.com/generic-eff-xr) reported the first generic version of Effexor extended release  (XR) capsules (venlafaxine hydrochloride) to treat major depressive disorder has been approved by the U.S. Food and Drug Administration.  Teva said it will start shipping its version of Effexor, or venlafaxine, on July 1st, 2020. The Israeli company originally sought approval for its generic in 2006, but as part of a patent settlement with Wyeth  it agreed not to sell its version until July 1, 2010. Pfizer acquired Wyeth last year.  As the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.  Teva said annual U.S. sales of Effexor XR are around $2.75 billion.

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