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November 8, 2021 – EprontiaTM (topiramate) 25mg/mL oral solution has received U.S. FDA approval to treat seizures and prevent migraines in children and adults.
- The new approval grants three indications to Eprontia:
- Use as a monotherapy to treat partial-onset or primary generalized tonic-clonic seizures in patients at least two years of age;
- Use as adjunctive therapy to treat partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox Gastaut syndrome in patients at least two years old; and
- Use as a monotherapy for preventive treatment of migraines in patients who are at least 12 years old.
- Eprontia is the first and only FDA-approved ready-to-use liquid formulation of topiramate, its active pharmaceutical ingredient.
- Recommended dosing is determined by multiple factors, including the patient's age and weight, the condition being treated, and the clinical response to treatment.
- Azurity Pharmaceuticals, the manufacturer, has launched Eprontia at a wholesale acquisition cost (WAC) of $665 per 473mL bottle.