Drug firm Alembic Pharmaceuticals on Monday said it has received tentative 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 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.
Alembic said it is currently in litigation with Pfizer in District Court of Delaware and launch of the product will depend on litigation outcome.
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.