28 June 2023 | News
Newly approved Perampanel Oral Suspension formulation is now available in 100 ml bottles, with a strength of 0.5mg/ml
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Akums, New Delhi-based Contract Development and Manufacturing Organisation (CDMO), has announced the first-time approval of Perampanel Oral Suspension by the Drug Controller General of India (DCGI).
This groundbreaking 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.
According to a report by the World Health Organisation (WHO) around 50 million people worldwide have epilepsy, making it one of the most common neurological diseases globally. An estimated 5 million people are diagnosed with epilepsy every year. India has more than 10 million patients with epilepsy, i.e., 20% out 50 million worldwide.
The newly approved Perampanel Oral Suspension formulation is now available in 100 ml bottles, with a strength of 0.5mg/ml. The packaging includes a convenient oral dosing applicator ensuring accurate dosage administration and enhancing patient compliance.
Akums' achievement in obtaining the DCGI approval for Perampanel Oral Suspension further solidifies its position as a leader in the Central Nervous System (CNS) category.