Adams Resp gets "not-approvable letter" for Mucinex with Codeine
The US Food and Drug Administration has issued an "approvable letter" on New Jersey-based Adams Respiratory Therapeutics' New Drug Application for Mucinex with Codeine (guaifenesin 600/1,200mg and codeine phosphate 30/60mg) 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 drugmaker notes.
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 agency has requested additional data to support the use of the product with food, and has suggested various approaches to address this issue. Adams says it is evaluating the information and plans to respond to the FDA in a timely manner.
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