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
Excellent decision by DCGI need to be implement fasttrack.