FDA Expands Qudexy XR Monotherapy Age Range
The Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for Qudexy XR (topiramate; Upsher-Smith) extended-release capsules for monotherapy in patients ages 2–<10 years old with partial onset (POS) or primary generalized tonic-clonic (PGTC) seizures.
Prior to this approval, Qudexy XR was not recommended for use as monotherapy in patients <10 years old. The expanded approval was based on the fulfillment of the pediatric study requirements for initial monotherapy in POS and PGTC seizures in patients aged 2–<10 years old. Qudexy XR is already approved as adjunct in Lennox-Gastaut Syndrome in ages ≥2 years old.
Qudexy XR is an anticonvulsant that is presumed to work through four properties: blocks voltage-dependent sodium channels; augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor; antagonizes the AMPA/kainate subtype of the glutamate receptor; and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.
Qudexy XR is supplied in 25mg, 50mg, 100mg, 150mg, and 200mg strength capsules in 30-, 90-, and 500-count bottles.
For more information call (800) 654-2299 or visit QudexyXR.com.