ARTICLE | Clinical News
Qsymia phentermine/topiramate regulatory update
May 12, 2014 7:00 AM UTC
Vivus disclosed in an SEC filing that it received notice from Actavis plc (NYSE:ACT, Dublin, Ireland) that the generics company submitted an ANDA to FDA for a generic version of Qsymia phentermine/topiramate to treat obesity. Vivus said the ANDA contains a paragraph IV certification that patents covering Qsymia are invalid, unenforceable and/or will not be infringed by the generic product. Vivus is reviewing the letter and said it intends to "vigorously" enforce its IP rights. Vivus has 45 days from May 7 - the date of receipt of the letter - to begin a patent infringement suit against Actavis. ...