“Paper NDAs”
This article was originally published in The Tan Sheet
Executive Summary
Pursuing Rx-to-OTC switches under section 505(b)(2) of Hatch/Waxman patent law is "potentially a very good avenue" for companies to use, Morgan Lewis lawyer Stephen Paul Mahinka says at Regulatory Affairs Professionals Society annual conference in Washington, D.C. Oct. 9. Both Wyeth and McNeil used 505(b)(2) application, or "paper NDA," approach to seek OTC approval for loratadine (Schering-Plough's Claritin) (1"The Tan Sheet" Feb. 4, 2002, p. 3). Mahinka expects "some response" from FDA in next several months on citizen petition filed by Pfizer and Pharmacia in 2001 requesting FDA disallow 505(b)(2) NDAs from relying on innovator's data...