FDA requests more data on Adams cough drug

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 new drug application (NDA) and that it is approvable. In addition to some preliminary labeling comments, the FDA has requested additional data to support the use of the product with food, and has suggested various approaches to address this issue.

Robert Casale, chief operating officer of Adams Respiratory Therapeutics, said: “An approvable letter for Mucinex with Codeine is a positive step in the FDA review process. As a next step, we intend to seek a meeting with the agency in order to agree on an approach. We will then move as expeditiously as possible to fulfill the requirements for final approval.”