CHESTER, NJ (May 17, 2004) – The U.S. Food & Drug Administration (FDA) last week gave Adams Respiratory Therapeutics the go-ahead to begin selling its Mucinex cough medicine over the counter. Adams is expected to begin marketing the drug in nationwide pharmacies in September.
‘ The FDA approval is for Mucinex DM in two strengths, extended release guaifenesin 600 mg/dextromethorphan HBr 30 mg and guaifenesin 1200 mg/dextromethorphan HBr 60 mg.
The move represents the first FDA approval of an extended release combination product containing guaifenesin and dextromethorphan, according to the company. Such products have previously been available by prescription only. In July 2002, Adams received FDA approval for Mucinex extended release guaifenisin 600/1200 mg.
The company has also filed a New Drug Application and has received an approvable letter for Mucinex D extended release guaifenesin 600 mg/pseudoephedrine 60 mg and guaifenesin 1200 mg/pseudoephedrine 120 mg, the company said.
Adams Respiratory Therapeutics develops, markets and sells prescription and non-prescription pharmaceuticals for the treatment of respiratory disorders and diseases.