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UPDATED: Zetia/Lipitor Combo’s Ongoing Clinical Equivalence Trials May Address FDA’s Data Request, Merck Says

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA did not accept the company’s bioequivalence arguments supporting a fixed-dose combination of ezetimibe and atorvastatin. Merck believes new data that are expected to be available later this year may address the agency’s “complete response” letter.

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Novo Nordisk and Allergan both report setbacks during their respective first quarter earnings calls. Meanwhile, Valeant and Actavis avoid speculation about a potential merger, and other Q1 happenings.

With Singulair Gone, It’s Test Time For Merck’s Post-LOE Strategy

With Singulair’s loss of exclusivity on Aug. 3, Merck’s bets on growth of its existing franchises and late-stage pipeline have come under scrutiny. Next up: Tredaptive Phase III data in early 2013.

The SHARP “Approval”: Merck Gets Vytorin Labeling Change, But Not The CV Outcomes Claim It Sought

FDA opted against a new indication for the ezetimibe/simvastatin combination because the SHARP trial in chronic kidney disease patients did not assess the independent contributions of each drug on the observed effect. There was no indication at a November advisory committee review that issues related to the “combination rule” would pose a barrier to a new claim.

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