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Contract manufacturing drug firm Akums Drugs & Pharmaceuticals on Tuesday said DCGI has approved its formulation to treat certain types of seizures in patients with epilepsy.
The 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 company said in a statement.
The company's product is a bioequivalent formulation of the USFDA-approved Fycompa (perampanel) Oral Suspension.
India has more than 10 million patients with epilepsy, as per the company.
"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," Akums Drugs & Pharmaceuticals Joint Managing Director Sanjeev Jain stated.
The newly-approved Perampanel Oral Suspension formulation is now available in 100mL bottles, with a strength of 0.5mg/mL, the company said.
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