Table 3.

Year of initial FDA approval and inclusion in class warning for drug formulations receiving new and incremental BBWs.

		Year of initial FDA approval
		Pre-1992	1992–1996	1997–2001	2002–2006	2007 or later
All new BBWs & major updates	Class warnings	49	9	27	17	10
	Non-class warnings	25	9	17	20	17
	Total	74	18	44	37	27
New BBW	Class warnings	16	3	8	5	0
	Non-class warnings	7	1	5	9	7
	Total	23	4	13	14	7
Major BBW update	Class warnings	33	6	19	12	10
	Non-class warnings	18	8	12	11	10
	Total	51	14	31	23	20
Minor BBW update	Class warnings	17	8	11	7	6
	Non-class warnings	9	10	18	12	13
	Total	26	18	29	19	19

BBW: Black Box Warning; FDA: U.S. Food & Drug Administration.