Akums gets DCGI approval for Perampanel Oral Suspension

Akums has received first-time approval of Perampanel Oral Suspension by the Drug Controller General of India (DCGI). This approval allows Perampanel Oral Suspension to serve as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalised seizures, as well as primary generalised tonic-clonic (PGTC) seizures in patients with epilepsy aged 12 years and older in the country. The Perampanel Oral Suspension is a bioequivalent formulation to the US FDA approved FYCOMPA (perampanel) Oral Suspension.

“We are excited about the approval of Perampanel Oral Suspension, as it provides another treatment option for patients with epilepsy who may have difficulty swallowing tablets or prefer liquids,” said Sanjeev Jain, Jt. MD, Akums Drugs & Pharmaceuticals.

Sandeep Jain, Jt. MD, Akums Drugs & Pharmaceuticals said, “Perampanel represents an important new option for the treatment of partial-onset epilepsy, and it holds the potential to play a key role in improving seizure management, particularly in poorly controlled adults and adolescents.”

The newly approved Perampanel Oral Suspension formulation is available in 100mL bottles, with a strength of 0.5mg/mL.