Alembic Pharma secures USFDA nod for breast cancer drug Palbociclib
Vadodara: Alembic Pharmaceuticals Limited today announced that the Company 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.
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