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news.Upsher-Smith Laboratories (Upsher-Smith), has announced the launch of Topiramate Extended-Release Capsules, the authorized generic of the recently Food and Drug Administration (FDA) approved Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.
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Qudexy XR and Topiramate Extended-Release Capsules are indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures. They are also approved as adjunctive therapy in patients two years of age and older with POS, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.
Like Qudexy XR, the generic offers patients flexibility. All strengths of both Qudexy XR and Topiramate Extended-Release Capsules may be swallowed whole or administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of soft food. This makes them the only approved extended-release topiramate products for patients who experience challenges swallowing whole capsules or tablets.
"At Upsher-Smith, we are breaking the traditional mold and making a generic equivalent to Qudexy XR available immediately so that clinicians and their patients have faster and more affordable access to our quality extended-release topiramate, which is manufactured using the same materials and process as the brand," said Mark Evenstad, President and Chief Executive Officer of Upsher-Smith.
"This launch reflects our commitment to simplify access to effective treatments and provide quality, high-value products to patients."
Qudexy XR and its authorized generic are available in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg strengths.
Qudexy XR (topiramate) extended-release capsules and Topiramate Extended-Release Capsules are prescription medicines used:
- to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 10 years of age and older,
- with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older.