AstraZeneca gets DCGI nod for import and marketing of prostate cancer drug

Our Bureau Bengaluru | Updated on August 20, 2020

AstraZeneca Pharma India Limited has got the Drugs Controller General of India’s marketing authorisation for its Olaparib film-coated tablets 100 mg and 150 mg-additional indication.

The company said the DCGI’s permission is for import and market permission, through this approval. Olaparib film-coated tablets are additionally indicated as a monotherapy for treatment of adult patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations (germline and/or somatic) who have progressed following a prior new hormonal agent.

“The receipt of this import and market permission paves way for the launch of Olaparib film-coated tablets 100 mg and 150 mg (Lynparza) in India for the specified additional indication, subject to the receipt of related statutory approvals and licences,” the company said.

Published on August 20, 2020

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