AstraZeneca gets DCGI nod to import and market Olaparib film coated tablets

AstraZeneca Pharma India informed that it has received import and market permission in Form CT-20 (marketing authorisation) from the Drugs Controller General of India (DCGI) for Olaparib film-coated tablets 100 mg and 150 mg – additional indication.

Through this approval, Olaparib film-coated tablets 100 mg and 150 mg is additionally indicated as a monotherapy for the 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 licenses.