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Pipeline:
Our product pipeline will change over time as compounds move through the drug development process, due to the nature of the development process. This description contains forward-looking statements that involve significant risks and uncertainties, including those discussed in Santarus’ most recent Form 10-K and in Santarus’ periodic reports on Form 10-Q and Form 8-K, and actual results may vary materially. Santarus does not undertake any obligation to update any forward-looking statements contained in this table as a result of new information, future events or otherwise.
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*GSK is also currently promoting Zegerid® Rx products in Puerto Rico and USVI. Regulatory submissions made in Latin America and Africa.
Phase I clinical trials investigate safety and proper dose ranges of a product candidate in a small number of human subjects.
Phase II clinical trials investigate side effect profiles and efficacy of a product candidate in a large number of patients who have the disease or condition under study.
Phase III clinical trials investigate the safety and efficacy of a product candidate in a large number of patients who have the disease or condition under study.
NDA (New Drug Application) submitted to FDA or foreign regulatory authority for review and approval.
Marketed therapies are available for prescribed users to patients in countries that have granted regulatory clearance.
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