MSN Laboratories Gets CDSCO Panel Nod To Manufacture, Market Lurasidone Tablets 60 mg, 120 mg for Schizophrenia
New Delhi: MSN Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Lurasidone Hydrochloride Tablets 60 mg and 120 mg for the treatment of patients with schizophrenia.
This came after MSN Laboratories presented their proposal for a grant of permission to manufacture and market Lurasidone Hydrochloride Tablets 60 mg and 120 mg (Additional Strength) for the treatment of patients with schizophrenia, along with a bioequivalence (BE) study report of Lurasidone Hydrochloride 80 mg tablets and justification for a waiver of clinical trial before the Committee.
The firm has informed that they are already holding marketing authorization (MA) permission for Lurasidone Hydrochloride Tablets 40 mg and 80 mg for the treatment of patients with schizophrenia, which was approved by CDSCO on 18.07.2016.
Furthermore, the firm has informed that they got approval from the USFDA for all the strengths of Lurasidone Hydrochloride 40 mg, 60 mg, 80 mg, and 120 mg tablets.
Lurasidone is an atypical antipsychotic used to treat schizophrenia and depressive episodes associated with bipolar I disorder. Lurasidone is an atypical antipsychotic. It is thought that antagonism of serotonin receptors can improve negative symptoms of psychoses and reduce the extrapyramidal side effects that are often associated with typical antipsychotics.
Lurasidone hydrochloride, an atypical antipsychotic, exerts its effects primarily by modulating dopamine and serotonin neurotransmitter systems in the brain. Specifically, it acts as a mixed dopamine and serotonin antagonist, meaning it blocks the actions of both neurotransmitters on specific receptors.
At the recent SEC meeting for neurology and psychiatry held on 19th March 2025, the expert panel reviewed the proposal for grant of permission to manufacture and market Lurasidone Hydrochloride Tablets 60 mg & 120 mg (Additional Strength) for the treatment of patients with schizophrenia along with the BE study report of Lurasidone Hydrochloride 80 mg tablets and justification for waiver of clinical trial.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market Lurasidone Hydrochloride Tablets 60 mg and 120 mg (Additional Strength) for the treatment of patients with schizophrenia.
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