Wednesday, 19 September 2018

Astrazeneca gets import and market permission for its cancer drug

09 August 2018 | News

The approval has been granted for Osimertinib Tablet in the strengths of 40 mg and 80 mg.

 Astrazeneca Pharma has received Import and Market permission in Form 45 (Marketing Authorization- Additional Indication) from the Drugs  Controller General of India .

 

The approval has been for Osimertinib Tablet 40 mg and 80 mg (TagrissoTM) indicated as first-line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumours have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions mutations.

 

The receipt of this Import and Market permission paves way for the launch of Osimertinib Tablets (TagrissoTM) for first-line treatment of patients in India, subject to the receipt of other related statutory approvals and licenses.

 

The first-line use of Osimertinib offers potential new standard of care.

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