On April 26, 2013, the FDA approved Teva’s Abbreviated New Drug Application for levalbuterol inhalation solution, its generic version of Sunovion’s Xopenex. Teva is offering three strengths: 0.31 mg, 0.63 mg, and 1.25 mg. The FDA had previously approved Mylan’s version of the product in March of this year.
In 2009, Sepracor (now Sunovion) announced that it had reached a settlement agreement with Teva and its subsidiary Barr Pharmaceuticals in a patent infringement suit, giving Barr and Teva a non-exclusive license to market generic levalbuterol inhalation solution beginning in February 2013.
