AstraZeneca Pharma India has received import and market permission in Form 45 (Marketing Authorization) from the Drug Controller General of India for Osimertinib Tablet 40 mg and 80 mg. The receipt of this import and market permission paves way for the launch of Osimertinib Tablets (Tagrisso TM) in India, subject to the receipt of other related statutory approvals and licenses.
Osimertinib (Tagrisso TM) is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an appropriate test, whose disease has progressed on or after EGFR TKI therapy. Osimertinib (Tagrisso TM) is the first-in-class oral medication for advanced EFGR T790M mutation positive Non-Small Cell Lung Cancer.
Osimertinib (Tagrisso TM) is the product of AstraZeneca group and has been approved in over 45 countries, including US, EU, Japan, China and other Asian countries.