Mucinex supplemental NDA approved
This article was originally published in The Tan Sheet
Executive Summary
More than a year after Reckitt Benckiser acquired Adams Respiratory Therapeutics, the firm receives FDA's approval to change the debossing of the modified release layer from "A" to "RB" on its MucinexExtended-Release Bi-Layer tablets, according to an April 3 approval letter for a supplemental new drug application (1"The Tan Sheet" Feb. 4, 2008, In Brief). The FDA also approved changing the tablet shape from round to modified oval and allows for blister packaging. Another April 3 FDA approval letter allows Reckitt to change the debossing of the MR layer of Mucinex DM Extended-Release Bi-Layer tablets from "Adams" to "RB.