AstraZeneca Pharma India Ltd has received import and market permission in Form CT-20 (subsequent to New Drug Approval) from the Drugs Controller General of India (DCGI) for Osimertinib 40mg/80mg film coated tablets (Tagrisso).
In a regulatory filing to exchanges, the company said Osimertinib 40mg/80mg film coated tablets as a monotherapy was approved for additional indication for adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC), whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
The receipt of this permission paves the way for the launch of Osimertinib 40mg/80mg film coated tablets in a new disease area in India, subject to the receipt of related statutory approvals and licenses.