Zydus Lifesciences Ltd
on Wednesday said it has received tentative approval from the US health regulator for its generic Palbociclib tablets used to treat a certain type of breast cancer. The tentative approval by the US Food and Drug Administration
) is for Palbociclib tablets of strengths 75 mg, 100 mg, and 125 mg, Zydus Lifesciences said in a regulatory filing.
The drug is used to treat a certain type of breast cancer. It works by slowing or stopping the growth of cancer cells.
The product will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad, it added.
Palbociclib tablets, 75 mg, 100 mg, and 125 mg had annual sales of USD 3.3 billion in the US, the company said citing IQVIA MAT April 2023 data.