Mucinex with CodeineTreatment for Cough
Adams Respiratory Therapeutics' NDA Submission for Prescription Cough Suppressant Accepted by FDA
First Extended-Release Guaifenesin Combination Prescription Product For Cough
CHESTER, N.J., March 14, 2007 -- Adams Respiratory Therapeutics, Inc. today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) for 600 mg and 1200 mg oral solid extended-release guaifenesin combination products for the prescription treatment of cough has been accepted for filing and is under formal review by the FDA. The FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review.
The Prescription Drug User Fee Act (PDUFA) date for the NDA submission is Oct. 27, 2007. The PDUFA date is the date by which the FDA has set as a goal to review and act on the NDA submission. There is no guarantee that final marketing approval will be granted by the PDUFA date.
This NDA submission represents the first prescription product in Adams' current portfolio of respiratory products. The prescription market for products that treat cough is significant, with approximately 24 million prescriptions written each year by U.S. physicians, according to IMS Health.
Posted: March 2007
- Adams Respiratory Therapeutics Receives Approvable Letter From FDA for Mucinex With Codeine - October 29, 2007
- Adams Respiratory Therapeutics Seeks Approval for New Prescription Cough Suppressant - December 27, 2006