In Brief

FDA proposes tweaking the regulations for citizen petitions that seek agency action against abbreviated new drug applications. In a Jan. 3 Federal Register notice, FDA proposes requiring such petitions – filed under section 505(q) of the Food, Drug and Cosmetic Act – to include a certification or verification that the petition includes data “known to the petitioner which are unfavorable to the citizen petition.” While negative data already are required, there is no rule obligating verification by the petitioner. Perrigo Co. PLC is using the 505(q) strategy in an attempt to block other generic versions of Prevacid 24HR (lansoprazole) if their ANDAs cite bioequivalence with the drug’s Rx version Also see "Perrigo Seeks To Slow Rivals’ Private-Label Prevacid Launches" - Pink Sheet, 5 December, 2011..

The agency will not issue warning letters to homeopathic OTC marketer , as sought by the Center for Inquiry. The...