AstraZeneca Pharma surrenders marketing authorisation of prostate cancer treatment drug in India

15 Apr 2025 Evaluate

AstraZeneca Pharma India has surrendered the marketing authorisation of prostate cancer treatment drug Olaparib (Lynparza) 100mg and 150mg in India citing commercial reasons. The company had received marketing authorisation for Olaparib film-coated tablets 100mg and 150mg (Lynparza) on November 17, 2023.

Since the date of receipt of marketing authorisation for the said indications till date, the company has never marketed the said indication in India. The discontinuation decision is only on the basis of commercial reasons and is not due to efficacy or safety reasons.

The drug is indicated in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer. The company continues to hold all other existing permissions for the said drug Olaparib in India.

AstraZeneca Pharma India is a global biopharmaceutical company. The company is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease. The company operates through two segments Healthcare and Clinical Trial.


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