Archive for November 3rd, 2009

FDA Refuse to File: Merck Zetia & Pfizer Lipitor

Merck disclosed that FDA refused to file its 505(b)(2) NDA for the combination of Pfizer’s Lipitor (atorvastatin) with Zetia (ezetimibe).  According to Merck’s disclosure, the FDA reason for he refusal is:
The FDA has identified additional manufacturing and stability data that are needed and the Company is assessing the FDA’s response in order to determine a [...]