FDA News

Adams Respiratory Therapeutics Receives Approvable Letter From FDA for Mucinex(R) With Codeine

(Oct 30, 2007)-- Adams Respiratory Therapeutics announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter related to the New Drug Application (NDA) for Mucinex 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 requested additional data to support the use of the product with food, and has suggested various approaches to address this issue. Adams is evaluating the information contained in the letter and plans to respond to the FDA in a timely manner.

"An approvable letter for Mucinex with Codeine is a positive step in the FDA review process," said COO Robert D. Casale. "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."

Adams does not expect this development to impact its financial guidance for fiscal 2008. The Company's previously stated net sales guidance issued on Aug. 21, 2007, did not include any potential revenue from Mucinex with Codeine.

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