Mucinex with Codeine receives approvable letter from FDA
CHESTER, N.J. The Food and Drug Administration has issued an approvable letter to Adams Respiratory Therapeutics application for Mucinex with Codeine and codeine phosphate extended-release bi-layer tablets.
In addition to some preliminary labeling comments, the FDA has requested additional data to support the use of the product with food. “An approvable letter for Mucinex with Codeine is a positive step in the FDA review process,” said chief operating officer Robert D. Casale.
The company also announced that its fiscal 2008 will be close to $440 million. The new Mucinex with Codeine is not expected to impact this number. The company will release these results on Nov. 8th.