The US Food & Drug Administration (FDA) has issued a tentative approval letter to Supernus Pharmaceuticals for its Trokendi XR (extended release topiramate) in the treatment of epilepsy.
Following to completion of review of the Trokendi XR new drug application as revised in December 2012, the regulator approved the product for use as recommended in the submitted and agreed-upon labeling.
Supernus chief executive officer, president and director Jack Khattar said, "As expected and as previously communicated, most recently during our May 13, 2013 quarterly earnings call, since this approval was granted before the June 22, 2013 date of expiration of the Topamax data exclusivity, this approval came in the form of a tentative approval."
The company will now submit the Request for Final Approval letter to the FDA and upon clearance, the product is expected to be launched in the third quarter of 2013.
