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VBCN - July 2015 Volume 2, No 2 - FDA Approvals, News & Updates

The FDA has approved an expanded indication for topiramate extended-release capsules (Qudexy XR; Upsher Smith Laboratories, Inc), a once-daily, broad-spectrum antiepileptic drug for the treatment of partial-onset seizures (POSs) or primary generalized tonic-clonic seizures in patients aged ≥2 years.

Topiramate extended-release capsules were previously approved for use in patients aged ≥10 years as initial monotherapy for POSs or primary generalized tonic-clonic seizures, and as adjunct therapy in patients aged ≥2 years with POSs or primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.

“The expanded indication gives physicians the option to prescribe Qudexy XR as initial monotherapy in patients as young as 2 years old,” said William Pullman, MB, BS, BMedSc, PhD, FRACP, Chief Scientific Officer, Upsher-Smith Laboratories, Inc, Morristown, NJ. “This, combined with its ability to be sprinkled on soft food for ease of administration, makes it a viable treatment option for the pediatric patient population,” he added. (June 1, 2015)

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Last modified: August 5, 2015
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