FDA approves Teva's generic Effexor XR antidepressant

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Jun 29 2010

Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today U.S. Food and Drug Administration (FDA) approval of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR®. Shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth.

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.

The brand product had annual sales of approximately $2.75 billion in the United States, based on IMS sales data.

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Teva Pharmaceutical Industries Ltd.,

Posted in: Medical Condition News | Pharmaceutical News

Tags: Antidepressant, Biotechnology, Endoplasmic reticulum (ER), Food, Medicaid, Medicare, New Drug Application, Pharmaceuticals, Protonix, Venlafaxine

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