AstraZeneca Pharma India Ltd on Tuesday said it 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, AstraZeneca Pharma India said in a regulatory filing.
It has now surrendered the marketing authorisation of the indication of Olaparib (Lynparza) 100mg and 150mg, the filing added.
"...since the date of receipt of marketing authorisation for the said indications i.e. November 17, 2023, till date, we have never marketed the said indication in India," the company said, adding, "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, AstraZeneca Pharma India said, adding, it continues "to hold all other existing permissions for the said drug Olaparib in India".
It has now surrendered the marketing authorisation of the indication of Olaparib (Lynparza) 100mg and 150mg, the filing added.
"...since the date of receipt of marketing authorisation for the said indications i.e. November 17, 2023, till date, we have never marketed the said indication in India," the company said, adding, "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, AstraZeneca Pharma India said, adding, it continues "to hold all other existing permissions for the said drug Olaparib in India".
