Chronic Bronchitis
Adams Respiratory Therapeutics Receives Approvable Letter From FDA for Mucinex(R) With Codeine
Published in Medical Letter on the CDC and FDA, November 18th, 2007
Adams Respiratory Therapeutics, Inc. (NASDAQ:ARxT) announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter related to the New Drug Application (NDA) for Mucinex(R) with Codeine (guaifenesin 600/1200 mg and codeine phosphate 30/60 mg) extended-release bi-layer tablets. The approvable letter relates to the use of Mucinex with Codeine in the prescription treatment of cough associated with the common cold, inhaled irritants and stable chronic bronchitis.
The FDA stated in the letter that it has completed its review of the Mucinex with Codeine NDA and that it is approvable. In addition to some preliminary labeling comments, the FDA has...
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