AstraZeneca Pharma Receives Nod From DCGI For Osimertinib Tablets

AstraZeneca Pharma Limited on Monday announced that it has received import and market permission in Form 45 (Marketing Authorisation) from the Drug Controller General of India (DCGI) for Osimertinib tablet 40 mg and 80 mg.

The receipt of the import and market permission pave the way for the launch of Osimertinib tablets (Tagrisso) in India, subject to the receipt of other related statutory approvals and licenses.

Osimertinib (Tagrisso) is the product of AstraZenca group and has been approved in over 45 countries, including US, EU, Japan, China and other Asian Countries.

Osimertinib (Tagrisso) is indicated for the treatment of patients with metastatic epidermal growth factor (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.

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