FDA approves Teva's generic Effexor XR antidepressant

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.

Source:

Teva Pharmaceutical Industries Ltd.,

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

Sign in to keep reading

We're committed to providing free access to quality science. By registering and providing insight into your preferences you're joining a community of over 1m science interested individuals and help us to provide you with insightful content whilst keeping our service free.

or

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Why Salmonella Dublin poses a food safety threat in beef and dairy