AstraZeneca Pharma India Receives Permission for Additional Indication of Osimertinib Tablets
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 as monotherapy to be indicated for the treatment of patients with locally advanced, unresectable (stage I11) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy. 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, if any.
Key Highlights
- AstraZeneca Pharma India Ltd has received permission from the Central Drugs Standard Control Organization for an additional indication of Osimertinib Tablets 40 mg & 80 mg (TAGRISSO).
- The additional indication allows Osimertinib as monotherapy for the treatment of patients with locally advanced, unresectable (stage I11) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
- 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, if any.