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.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.