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USFDA Approval for breast cancer treatment drug to Alembic Pharma

November 10, 2020

Drug firm Alembic Pharmaceuticals on Monday said it has received uncertain approval from the US health regulator for Palbociclib capsules, used to treat a certain type of breast cancer. The approved product is therapeutically equivalent to the reference listed drug product lbrance Capsules of Pfizer NSE 7.44 % Inc.

"The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) in the strengths of Palbociclib capsules, 75 mg, 100 mg, and 125 mg," Alembic Pharmaceuticals said in a regulatory filing.

Citing IQVIA data, Alembic Pharma said Palbociclib capsules, 75 mg, 100 mg, and 125 mg, have an estimated market size of USD 624 million for 12 months ending June 2020.

Alembic Pharma now has a total of 135 ANDA approvals (117 final approvals and 18 tentative approvals) from USFDA.


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