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AstraZeneca Surrenders Marketing Authorisation for Prostate Cancer Drug in India

AstraZeneca Surrenders Marketing Authorisation for Prostate Cancer Drug in India AstraZeneca Pharma India Ltd has relinquished the marketing authorisation for its prostate cancer treatment, Olaparib (Lynparza), citing commercial reasons. This decision affects the distribution of the 100mg and 150mg doses in the Indian market.The regulatory filing confirmed that the authorisation for these formulations was initially granted on November 17, 2023. However, AstraZeneca never commenced marketing the drug in India.The company emphasized that the withdrawal was based solely on commercial factors and was unrelated to any concerns regarding the drug’s efficacy or safety. Despite this, AstraZeneca will maintain all existing permissions for other uses of Olaparib in the country.

AstraZeneca Pharma India Ltd has relinquished the marketing authorisation for its prostate cancer treatment, Olaparib (Lynparza), citing commercial reasons. This decision affects the distribution of the 100mg and 150mg doses in the Indian market. The regulatory filing confirmed that the authorisation for these formulations was initially granted on November 17, 2023.

However, AstraZeneca never commenced marketing the drug in India. The company emphasized that the withdrawal was based solely on commercial factors and was unrelated to any concerns regarding the drug's efficacy or safety. Despite this, AstraZeneca will maintain all existing permissions for other uses of Olaparib in the country.

(With inputs from agencies.).