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Alembic Pharma bags USFDA nod for mantle cell lymphoma drug Acalabrutinib
Acalabrutinib Capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Mumbai: Drugmaker, Alembic Pharmaceuticals Limited today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Acalabrutinib Capsules, 100 mg.The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Calquence Capsules, 100 mg, of AstraZeneca UK Limited....
Mumbai: Drugmaker, Alembic Pharmaceuticals Limited today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Acalabrutinib Capsules, 100 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Calquence Capsules, 100 mg, of AstraZeneca UK Limited.
Acalabrutinib Capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Acalabrutinib Capsules, 100 mg, have an estimated market size of US $1.5 billion for twelve months ending Sep 2022 according to IQVIA.
Alembic has a cumulative total of 180 ANDA approvals (157 final approvals and 23 tentative approvals) from USFDA.
Read also: Alembic Pharma bags USFDA nod for Fesoterodine Fumarate ER Tablets to treat overactive bladder
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751