Zydus Lifesciences gets CDSCO Panel nod to study Aprepitant powder for Oral Suspension
New Delhi: Granting approval for conducting a bioequivalence (BE) study of Aprepitant powder for Oral Suspension 125 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined to the drug maker Zydus Lifesciences that the decision on the Phase III clinical trial may be taken after review of the bioequivalence (BE) study result.
This came after Zydus Lifesciences presented the proposal for a grant of permission to manufacture and market Aprepitant powder for Oral Suspension 125 mg along with BE protocol and justification for a clinical trial (CT) study waiver.
The firm informed that the Aprepitant powder for Oral Suspension 125 mg is already approved in the USA, EU, and UK, and Aprepitant capsules 40mg/80mg/125mg are already approved in India.
Aprepitant is a substance P/neurokinin 1 receptor antagonist used to treat nausea and vomiting caused by chemotherapy and surgery.
Aprepitant, an antiemetic, is a substance P/neurokinin 1 (NK1) receptor antagonist that, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors.
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