Intas Pharmaceuticals Gets CDSCO Panel Nod for Palatability Study of Temozolomide powder for oral suspension
New Delhi: The drug major Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the palatability study (acceptability, taste and smell, and oro-mucosal safety) for the anti-cancer drug Temozolomide in pediatric patients with malignant gliomas.
This came after Intas Pharmaceuticals presented their proposal for a grant of permission to conduct the palatability study (acceptability, taste & smell, and oro-mucosal safety) for Temozolomide powder for oral suspension at 20 mg/ml (300 mg/15 ml) in pediatric patients with malignant gliomas, along with the palatability study protocol, before the committee.
Malignant gliomas, the most common subtype of primary brain tumors, are aggressive, highly invasive, and neurologically destructive tumors considered to be among the deadliest of human cancers.
The firm informed that the proposed formulation is not yet approved in India or anywhere in the world.
The firm further added that they have already conducted a comparative bioavailability study for Temozolomide powder for oral suspension at 20 mg/ml (300 mg/15 ml) with TEMODAL (Temozolomide) capsules at 250 mg and found that they meet the bioequivalence criteria.
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