Upsher-Smith announced that it has received U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) for Qudexy XR (topiramate) extended-release capsules for use as initial monotherapy in patients two years of age and older who are experiencing partial-onset seizures or primary generalized tonic-clonic seizures.

Qudexy XR capsules are the only once-daily extended-release topiramate product to have received this expanded indication and to be approved for administration by sprinkling their contents onto soft food, making them a useful option for young children who may have difficulty swallowing whole capsules or tablets. Qudexy XR is a once-daily, broad-spectrum anti-epileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

For more details, go to: http://www.upsher-smith.com/wp-content/uploads/110560-01-QXR-PR-Expanded-Indication-FINAL.pdf