Tablets

AstraZeneca Pharma India Limited 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.

AstraZeneca Pharma India Limited receives Import and Market Permission in Form CT-20 from the Drugs Controller General of India for Olaparib 100mg/150mg film coated tablets