Alembic Pharmaceuticals gets USFDA’s nod for Palbociclib Capsules

09 Nov 2020 Evaluate

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 $624 million for twelve months ending Jun 2020. Alembic is currently in litigation with Pfizer in District Court of Delaware and launch of the product will depend on litigation outcome. The company now has a total of 135 ANDA approvals (117 final approvals and 18 tentative approvals) from USFDA. 

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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