AstraZeneca Pharma India gets CDSCO nod to import, distribute lung cancer drug Osimertinib
Bangalore: AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organization (CDSCO), 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.
Through this approval, Osimertinib is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
Non-small cell lung cancer (NSCLC) is the most prevalent form of lung cancer, typically characterized by a slower growth and spread compared to small cell lung cancer.
The receipt of this permission paves way for the marketing of Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.