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www.fdanews.com/articles/89996-adams-seeks-approval-for-prescription-cough-suppressant

ADAMS SEEKS APPROVAL FOR PRESCRIPTION COUGH SUPPRESSANT

December 29, 2006

Adams Respiratory Therapeutics Dec. 27 announced that it has submitted a new drug application (NDA) to the FDA for 600-mg and 1200-mg oral solid extended-release guaifenesin combination products for the treatment of cough. This new drug represents the first prescription product in Adams' current portfolio of respiratory products.

Adams has two other guaifenesin-based combination products currently under development in addition to the ongoing clinical program for erdosteine, a mucoregulator product, currently in Phase IIb.

At this time, Adams is not disclosing the name of the second active ingredient in the combination product for competitive reasons. However, the prescription market for products that treat cough is significant.