New Launch5 Apr 2025, 12:02 am
AstraZeneca Pharma India Receives Permission for Osimertinib Tablets for Additional Indication
AI Summary
AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India to import for sale and distribution of Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) for an additional indication. This approval allows Osimertinib to be indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. The marketing of Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) in India for the specified additional indication is subject to the receipt of related statutory approvals.
Key Highlights
- AstraZeneca Pharma India Ltd has received permission from the Central Drugs Standard Control Organization for Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) for an additional indication.
- Osimertinib is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
- The marketing of Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) in India for the specified additional indication is subject to the receipt of related statutory approvals.