Zydus Lifesciences gets USFDA approval for Palbociclib tablets

Zydus Lifesciences on Wednesday said in the filing that it has received tentative approval from the United States Food and Drug Administration (USFDA) for Palbociclib tablets, which are available in 75 mg, 100 mg, and 125 mg strengths.

The product will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad, the company said in the filing.

Palbociclib is used to treat a certain type of breast cancer and its works by slowing or stopping the growth of cancer cells.

As per IQVIA MAT April 2023, Palbociclib had annual sales of $3.3 billion in the US.

The group now has 373 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY2003-04.

 In the last week, Rising Sun Holdings Private Limited (the seller) and Mylab Discovery Solutions Private Limited reached an agreement with Zydus Animal Health and Investments Limited, a firm wholly controlled by Zydus Lifesciences.

This agreement states that Mylab will sell 6,506,500 equity shares, each with a face value of Rs 1, to Zydus Animal Health and Investments Limited. The agreed-upon total price for this transaction is Rs 106 crore or 6.5% of Mylab's total paid-up equity share capital.

Source: Media reports