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CHESTER, N.J., March 14 (UPI) -- Adams Respiratory Therapeutics said Wednesday the U.S. Food and Drug Administration accepted its application for a prescription cough drug.
The new drug application is for 600 mg and 1200 mg oral solid extended-release guaifenesin products for the prescription treatment of cough.
"The FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review," Adams said in a statement.
The FDA has set an action date for the NDA of Oct. 27.
If the cough suppressant is approved, it would be Adam's first prescription product. The company's current line includes the over-the-counter products, Mucinex and Delsym.
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