AstraZeneca receives DCGI approval for launch of Olaparib Film-Coated tablets in India

21 Aug 2022 , 01:31 AM

AstraZeneca Pharma India has received Import and Market permission in Form CT-20 Subsequent New Drug Approval from the Drugs Controller General of India 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 adjuvant treatment of adult patients with BRCA-mutated HER2- negative high risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy The receipt of this 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