AstraZeneca Pharma India surrenders marketing authorisation for specific indication of Olaparib
Bangalore: AstraZeneca Pharma India Limited has surrendered its marketing authorisation for Olaparib film-coated tablets 100mg and 150mg (Lynparza) for indication in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer.
Prostate cancer is a type of cancer that occurs in the prostate gland — a small, walnut-shaped gland in men that produces seminal fluid. It is one of the most common types of cancer among men, particularly those over the age of 50.
The Company had earlier received the marketing authorisation for the said medication in November 17, 2023.
However, in a recent statement, AstraZeneca confirmed that the company never marketed the said indication in India following the approval.
The decision to surrender the authorisation, the company clarified, was made purely for commercial reasons and is not related to any concerns regarding the efficacy or safety of the drug.
AstraZeneca also confirmed that the company continues to hold all other existing permissions for the said drug Olaparib in India.
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AstraZeneca India was established in 1979 and is headquartered at Bengaluru, Karnataka. AstraZeneca Pharma India Limited is the operating company and covers manufacturing, sales and marketing activities of the company in India.
It is a listed company and is a subsidiary of AstraZeneca Plc, UK.
