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This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the result of new information or future events or developments. IBRANCE is currently approved in more than 100 countries and has the potential for serious adverse reactions in nursing infants. The pharmacokinetics of IBRANCE and potential pediatric exclusivity for IBRANCE, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

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