AstraZeneca gets DCGI nod to import and market Olaparib film coated tablets
It is additionally indicated as a monotherapy to treat adults with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations
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
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Excellent decision by DCGI need to be implement fasttrack.