Impax Labs' generic Vytorin gets preliminary nod from FDA; shares up 19% premarket

• The FDA grants preliminary approval of Impax Laboratories' (IPXL) generic version of Merck's (MRK) cholesterol med VYTORIN (ezetimibe and simvastatin) in the 10/10, 10/20, 10/40 and 10/80 mg strengths. According to IMS Health, U.S. sales for the four strengths in 2015 were $714M.
• Preliminary approval means that the New Drug Application meets all the quality, safety and efficacy standards for clearance but is subject to an automatic stay of final approval for up to 30 months pending the resolution of a patent infringement suit.
• Shares are up 19% premarket but only on turnover of 100.