Alembic Pharmaceuticals receives USFDA tentative approval for Palbociclib Capsules

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Palbociclib Capsules, 75 mg, 100 mg, and 125 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), lbrance Capsules, 75 mg, 100 mg, and 125 mg, of Pfizer Inc. (Pfizer).

Palbociclib Capsule is a kinase inhibitor indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women; or in combination with fulvestrant in women with disease progression following endocrine therapy.

Palbociclib Capsules, 75 mg, 100 mg, and 125 mg have an estimated market size of US$ 624 million for twelve months ending Jun 2020 according to IQVIA. Alembic is currently in litigation with Pfizer in District Court of Delaware and launch of the product will depend on litigation outcome.

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

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