Zydus Lifesciences Limited has received tentative US Food and Drug Administration approval for its generic version of Pfizer’s Ibrance (palbociclib) tablets, teeing up the Indian firm to launch potentially its generic to the blockbuster treatment for HR-positive and HER2-negative breast cancer when a composition of matter patent expires later this decade.
Litigation remains ongoing between Pfizer and palbociclib abbreviated new drug application sponsors in US district courts, after ANDAs began
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