AstraZeneca Pharma India gets DCGI approval for Osimertinib tablets
It is now approved as monotherapy for adjuvant treatment after complete tumour resection in patients with NSCLC
AstraZeneca Pharma India has received Import and Market Permission in Form CT-20 (Subsequent New Drug Approval) from the Drugs Controller General of India for Osimertinib 40mg/80mg film-coated tablets (Tagrisso).
Osimertinib 40mg/80mg film-coated tablets as monotherapy is now approved for additional indication for the adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon19 deletions or exon 21 (L858R) substitution mutations.
The receipt of this permission paves way for the launch of Osimertinib 40mg/80 mg film-coated tablets into a new disease area in India, subject to the receipt of related statutory approvals and licenses.