Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection LusdunaTM NexvueTM, a follow-on biologic to Sanofi’s Lantus®. Because Merck’s application for insulin glargine was filed using the abbreviated 505(b)(2) regulatory pathway provided by the Hatch-Waxman Amendments (not a section (k) application
