BioCentury
ARTICLE | Company News

Actavis submits ANDA for Vivus' Qsymia

May 10, 2014 1:54 AM UTC

Vivus Inc. (NASDAQ:VVUS) disclosed in an SEC filing that it received notice from Actavis plc (NYSE:ACT) that the generics company submitted an ANDA to FDA for a generic version of Qsymia phentermine/topiramate to treat obesity. Vivus said it is reviewing the letter and intends to "vigorously" enforce its IP rights. Vivus reported 2013 Qsymia sales of $23.7 million. On Monday, the biotech reported $9.1 million in 1Q14 Qsymia sales, an 18% increase quarter-over-quarter.

Qsymia became available in certified retail pharmacies in July 2013 following FDA's approval of a REMS modification; distribution of the obesity drug was previously limited to certified mail-order pharmacies (see BioCentury Extra, April 16, 2013). ...