zydus lifesciences: Zydus Lifesciences gets tentative nod from USFDA for generic breast cancer drug

Zydus Lifesciences Ltd on Wednesday mentioned it has acquired tentative approval from the US well being regulator for its generic Palbociclib tablets used to deal with a sure kind of breast most cancers. The tentative approval by the US Meals and Drug Administration (USFDA) is for Palbociclib tablets of strengths 75 mg, 100 mg, and 125 mg, Zydus Lifesciences mentioned in a regulatory submitting.

The drug is used to deal with a sure kind of breast most cancers. It really works by slowing or stopping the expansion of most cancers cells.

The product can be manufactured on the group’s formulation manufacturing facility in SEZ, Ahmedabad, it added.

Palbociclib tablets, 75 mg, 100 mg, and 125 mg had annual gross sales of USD 3.3 billion within the US, the corporate mentioned citing IQVIA MAT April 2023 information.