Alkem Labs secures CDSCO panel nod to conduct BE study of anti epileptic drug
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) recommended for grant of permission to Alkem Laboratories to conduct BE study of Perampanel oral suspension 0.5 mg/ml as per proposed protocol to treat epilepsy.
This came after Alkem Labs presented the proposal for manufacturing and marketing of Perampanel oral suspension 0.5 mg/ml along with BE study protocol.
After detailed deliberation in its 81th meeting held on June 21, 2022 at CDSCO headquarter, New Delhi, the SEC (Neurology & Psychiatry) recommended for grant of permission to conduct BE study as per proposed protocol.
The expert panel further directed the drug maker that the result of Bioequivalence study should be submitted to CDSCO for further review by the committee.
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Medical Dialogues team had earlier reported that Alkem had announced the launch of Perampil (Perampanel) tablets 2 mg/4 mg/6 mg in India in June 2021. "This product reaffirms Alkem's commitment towards improving epilepsy care by bringing multiple treatment options of quality products to patients and health care professionals in India," the company had said.
The drug, Perampanel, was approved by the Drugs Controller General of India (DCGI), as an adjunctive therapy in treatment of partial onset seizures in patients with epilepsy aged 4 years and older and also as an adjunctive therapy in treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.
Also Read: Alkem Labs Launches Epilepsy Drug Perampil In India
Headquartered in Mumbai, Maharashtra, India Alkem Laboratories Limited is a multinational pharmaceutical company that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally.
