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.
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Medical Dialogues team had earlier reported that the company had also received permission from the CDSCO to import for sale and distribution of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for an additional indication. Following this approval, Durvalumab is now indicated for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
Read also: AstraZeneca Pharma India secures CDSCO nod to import, sell Durvalumab for small cell lung cancer
AstraZeneca India was established in 1979 and is headquartered at Bengaluru, Karnataka. AstraZeneca Pharma India Limited is the operating company and covers manufacturing, sales and marketing activities of the company in India.
It is a listed company and is a subsidiary of AstraZeneca Plc, UK.
Read also: AstraZeneca Pharma India to discontinue manufacturing, marketing of angina drug from April 1
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