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

19 Aug 2022 , 07:06 PM

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.Powered by Capital Market – Live News