Zydus Lifesciences secures tentative FDA approval for Palbociclib Tablets

Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has announced that it has been granted tentative approval by the US Food and Drug Administration (FDA) for its Palbociclib Tablets, in three dosages: 75 mg, 100 mg, and 125 mg.

The approved tablet corresponds with the US reference listed drug Ibrance Tablets of the same concentrations.

Palbociclib is a medication utilized in the treatment of a particular type of breast cancer. It functions by decelerating or halting the proliferation of cancer cells. The manufacturing process of the product is set to take place at Zydus’s formulation manufacturing facility, located in the Special Economic Zone (SEZ) of Ahmedabad, India.

Zydus Lifesciences gets tentative FDA approval for Palbociclib Tablets. Photo courtesy of Zydus Cadila.

In the United States, the annual sales of Palbociclib Tablets, at dosages of 75 mg, 100 mg, and 125 mg, reached up to $3.3 billion, as recorded by IQVIA MAT in April 2023.

This development marks Zydus Group’s 373rd approval. Since the initiation of the filing process in the fiscal year 2003-04, the group has submitted over 442 Abbreviated New Drug Applications (ANDAs).