Label Update for AstraZeneca's Olaparib Cleared by CDSCO Panel
New Delhi: In a recent regulatory update, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has approved the proposed revision to the prescribing information for Olaparib Tablets 100 mg and 150 mg, submitted by AstraZeneca Pharma India Limited.
The recommendation was made during the 19th SEC (Oncology) meeting held on 5th June 2025 at CDSCO headquarters in New Delhi. The proposal was based on the updated Company Core Data Sheet (CCDS) for Olaparib, reflecting changes to the drug’s safety and pharmacological profile.
As per the official minutes:
“The firm presented the proposal for update of prescribing information based on the Company Core Data Sheet of Olaparib Tablets 100 mg and 150 mg with respect to the changes in Special warnings and special precautions for use, Undesirable effects, Pharmacodynamic properties and Patient Information Leaflet.”
“After detailed deliberation, the committee recommended for grant of approval for the proposed update in prescribing information as presented by the firm.”
Olaparib is a first-in-class oral PARP inhibitor, approved for the treatment of ovarian, breast, pancreatic, and prostate cancers, especially in patients with BRCA mutations. The drug works by inhibiting the PARP enzyme, thereby preventing DNA repair in cancer cells and promoting cancer cell death.
AstraZeneca Pharma India Ltd, the Indian subsidiary of the UK-based biopharma major, has played a significant role in advancing targeted therapies in oncology. The approved revisions reflect the company’s continued alignment with global regulatory frameworks and reinforce CDSCO’s focus on pharmacovigilance.
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