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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.
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