Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Palbociclib Tablets, 75 mg, 100 mg, and 125 mg (USRLD: Ibrance Tablets, 75 mg, 100 mg, and 125 mg).
Palbociclib 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 (India).
Palbociclib Tablets, 75 mg, 100 mg, and 125 mg had annual sales of $3.3 billion in the United States (IQVIA MAT April 2023). The group now has 373 approvals and has so far filed over 442 (as of March 31, 2023) ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
