Further, Bharat Biotech was asked to present the details of the primary and secondary objectives and various assessments to be carried out in the subjects.
AstraZeneca Pharma India has received import and market permission in Form CT-20 (subsequent New Drug Approval) from the Drugs Controller General of India for osimertinib 40mg/80mg film coated tablets (Tagrisso).Osimertinib 40mg/80mg film coated tablets as monotherapy is now approved for additional indication for the adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
The receipt of this permission paves way for the launch of osimertinib 40mg/80mg film coated tablets into a new disease area in India, subject to the receipt of related statutory approvals and licenses, the company said in a statement.
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Union Health Minister Harsh Vardhan holds a dose of Bharat Biotech’s COVID-19 vaccine COVAXIN, during a vaccination campaign at the All India Institute of Medical Sciences in New Delhi on January 16, 2021. | Photo Credit:
REUTERS
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COVAXIN is one of the two vaccines approved for use in the country thus far and is being used as part of the immunisation programme rolled out on January 16. The Drugs Controller General of India (DCGI) had given the emergency use authorisation for the vaccine in clinical trial mode, raising questions about its effectiveness.
Read more about Dr Reddys initiates process for Emergency Use Authorization of Sputnik V on Business Standard. As part of the review process, Dr. Reddy s will present the safety profile of the phase 2 study, and interimdata of the phase 3 study, which is expected to complete by 21 February 2021.