AstraZeneca Pharma India Limited has informed the Exchange about General Updates

Regulatory Product ApprovalBusiness Updates View source PDF

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AI summary

AstraZeneca Pharma India has received permission from CDSCO (Central Drugs Standard Control Organisation) to import and sell Acalabrutinib tablets 100 mg (Calquence®) for a new indication. The drug is now approved for use in combination with venetoclax with or without obinutuzumab to treat previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). This expands the therapeutic use of Calquence® in India, though marketing is subject to related statutory approvals.

Likely market impact

This regulatory approval expands AstraZeneca's product portfolio in India, potentially increasing revenue from Calquence® by targeting a new patient population with CLL/SLL. Generally positive for shareholders as it opens a new market segment.