AstraZeneca Pharma India has received Import and Market permission in Form CT-20 (Subsequent New Drug Approval) 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 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 is a global biopharmaceutical company. The company is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease. The company operates through two segments Healthcare and Clinical Trial.
