Conduct Phase III CT : CDSCO panel tells AstraZeneca for anticancer drug Olaparib Film coated Tablet
Advertisement
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the drug major AstraZeneca to conduct the Phase III clinical trial of Olaprib film-coated Tablets 100mg/150mg for the additional indication as in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer.
This came after the firm presented the proposal for import and marketing of the drug Olaparib film-coated Tablets 100mg/150mg for the additional indication as “In Combination with Abiraterone and Prednisone or Prednisolone is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer” along with clinical trial waiver justification and some global clinical trial data, before the committee.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
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.