Early last month we blogged about the case Moore v. Mylan, Inc., 2012 U.S. Dist. LEXIS 6897 (N.D. Ga. Jan. 5, 2012) – another post-Mensing generic preemption case.  We noted that this was the first case to our knowledge to discuss in some detail plaintiffs’ new RLD theory.  If, like us, you had not until recently focused on generic pharmaceuticals we thought a little more detail might be helpful. 

For starters, let’s clarify that RLD in this context does not mean “red letter day,” “remote location device,” “restrictive lung disease,” or “red light district.”    In FDA jargon, it stands for Reference Listed Drug.  Let’s throw two more familiar acronyms in the mix:  NDA – New Drug Application and ANDA – Abbreviated New Drug Application.  To keep it simple we think of the NDA holder as the “brand” manufacturer and ANDA holders as “generic” manufacturers.  For an ANDA to be approved, the generic manufacturer has to establish that its drug is bioequivalent to the brand name drug.  It is along NDA/ANDA lines that the Supreme Court’s Mensing decision is anchored.

Please see full article below for more information.