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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