Mucinex NDA pipeline
This article was originally published in The Tan Sheet
Executive Summary
Adams Labs will submit NDAs in 2003 for respiratory products combining guaifenesin with pseudoephedrine and guaifenesin with dextromethorphan, firm says Jan. 21. Adams receives same-day FDA approval for 1,200 mg guaifenesin tablets (NDA 21-282/S-001), which will join 600 mg dose in March with similar behind-the-counter sales strategy. Mucinex 1,200 mg offers convenient dosing regimen of one tablet twice a day and is indicated to "help loosen phlegm" and "make coughs more productive." A 20-count bottle will retail for roughly $15, Adams says. Like Mucinex 600 mg, the higher dose will be promoted to physicians, pharmacists (1"The Tan Sheet" July 22, 2002, p. 3)...