Community/Retail

The approval is based on data from a multicenter trial in which patients were randomized 2:1 to receive either 30 mcg of the sufentanil sublingual tablet as needed, or placebo, with treatment limited up to 48 hours following the procedure.

The action, FDA officials explained in a press release, is based on new data that suggest there is no longer a reasonable certainty that there is no harm from the use of lead acetate as a color additive.