FDA Approves Epilepsy and Migraine Treatment
EPRONTIA (topiramate) oral solution, 25 mg/mL has been approved to treat certain seizures in patients two years of age or older and for use to prevent migraine in patients 12 years of age and older.
On Nov. 8, 2021, Azurity Pharmaceuticals announced FDA has approved EPRONTIA (topiramate) oral solution, 25 mg/mL to treat certain seizures in patients two years of age or older and for use to prevent migraine in patients 12 years of age and older. According to the company, it is the first liquid formulation of topiramate to be approved by FDA as a monotherapy for treating partial-onset or primary generalized tonic-clonic seizures and for use as an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.
“I am pleased that there will now be an FDA-approved liquid formulation of topiramate for patients who may require or prefer a liquid formulation,” said Michael C. Smith, MD, Director, Rush Epilepsy Center, and Professor, Department of Neurological Sciences, Rush University Medical Center, in a company press release. “Clinical challenges have existed for years for clinicians looking for a high quality, predictable formulation option of topiramate to effectively meet the varied needs of patients and caregivers.”
Source: Azurity Pharmaceuticals
Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency
March 14th 2025The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
