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.
At the recent SEC meeting for oncology, the expert panel reviewed the proposal for grant of permission to manufacture and market Aprepitant powder for oral suspension 125 mg along with BE protocol and justification for CT study waiver.
After detailed deliberation, the committee recommended granting permission to conduct the BE study as per the protocol presented by the firm.
Accordingly, the expert panel suggested that the firm should submit the BE study report to CDSCO for further review by the committee.
In addition to the above, the expert panel stated that a decision on the Phase III clinical trial may be taken after review of the BE study result.
Also Read: Pfizer Gets CDSCO Panel Nod To study Anti-cancer Drug Disitamab vedotin
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.