Zydus Lifesciences gets tentative nod from USFDA for Palbociclib tablets
New Delhi: Zydus Lifesciences 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.
Palbociclib is used to treat a certain type of breast cancer and its works by slowing or stopping the growth of cancer cells.
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The product will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad.
Zydus Lifesciences share price gained 1 percent in the early trade on June 30 after company received USFDA approval for breast cancer drug.
Palbociclib had annual sales of $3.3 billion in the US as per IQVIA MAT April 2023.
The group now has 373 approvals and has so far filed over 442 ANDAs since the commencement of the filing process in FY 2003-04.
Last week, Zydus Animal Health and Investments Limited, a wholly owned subsidiary company of Zydus Lifesciences has entered into a share purchase agreement with Rising Sun Holdings Private Limited (seller) and Mylab Discovery Solutions Private Limited to acquire 65,06,500 equity shares having face value of Re 1 each at an agreed consideration of Rs 106 crores representing 6.5% of the total paid-up equity share capital of Mylab from the seller.
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