The receipt of this permission paves way for the launch of the capsules in India
AstraZeneca Pharma has received approval from India’s drug regulator to market Acalabrutinib 100mg capsules, medicine for the treatment of chronic lymphocytic leukaemia.
“This is to inform that AstraZeneca Pharma India has received import and market permission from the Drugs Controller General (India) for Acalabrutinib 100mg capsules,” the company said in a BSE filing.
The receipt of this permission paves way for the launch of the capsules in India, subject to the receipt of related statutory approvals and licences, it said.
The capsule “is indicated for the treatment of patients with chronic lymphocytic leukaemia/ small lymphocytic lymphoma,” it added.