5/12/2014 7:18:23 AM
VIVUS, Inc. Reports Filing Of ANDA For Generic Qsymia By Actavis
On May 7, 2014, VIVUS, Inc. (Nasdaq: VVUS), or the Company, received notice from Actavis Laboratories FL, Inc. (NYSE: ACT), or Actavis, that it has filed with the U.S. Food and Drug Administration, or the FDA, an Abbreviated New Drug Application , or ANDA, for generic versions of all strengths of Qsymia (phentermine and topiramate extended release) capsules CIV. The notice from Actavis included a paragraph IV certification with respect to all of the Company’s patents listed in the FDA’s Orange Book on the date of the Company’s receipt of the notice. A paragraph IV certification is a certification by a generic applicant that patents covering the branded product are invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of the generic product.
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