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Update on LUVOX® (fluvoxamine maleate) Tablets

Solvay Pharmaceuticals, Inc. withdrew the new drug application (NDA) for LUVOX® (fluvoxamine maleate) Tablets in May 2002. Solvay Pharmaceuticals refiled its new drug application (NDA) for LUVOX® in late June 2002.

In February 2004, the company received an “approvable” letter from the FDA for the LUVOX® NDA.  The company is still in the process of responding to the FDA’s remaining questions. We do not have a specific timeline as to when the product will be re-introduced to the market. 

Because LUVOX® Tablets is not sold in the U.S. at this time, Solvay Pharmaceuticals is unable to respond to medical information requests for the product. Medical inquiries concerning fluvoxamine should be directed to the manufacturer of the generic fluvoxamine product prescribed.

In addition, the product is no longer available through the company’s Patient Assistance Program.

 

 

 

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Date of last update: 4/18/2008