Qudexy XR approval extended by FDA to patients two years of age and older who experience tonic-clonic seizures-Upsher Smith Labs

Upsher-Smith Laboratories, Inc. has announced that it has received 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 POS) 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 antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile. Qudexy XR was previously approved for use as initial monotherapy in patients 10 years of age and older with POS or primary generalized tonic-clonic seizures. Qudexy XR is also approved as an adjunctive therapy in patients two years of age or older with POS, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Qudexy XR has been available in the United States since June 2014.