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FDA APPROVES TWO STRENGTHS OF ADAMS RESPIRATORYS MUCINEX DM EXPECTORANT, COUGH SUPPRESSANT

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The Food and Drug Administration approved Adams Respiratory Therapeutics Mucinex DM expectorant and cough suppressant, the first approval of an extended-release combination product containing the active ingredients guaifenesin and dextromethorphan.

The Food and Drug Administration approved Adams Respiratory Therapeutics Mucinex DM expectorant and cough suppressant, the first approval of an extended-release combination product containing the active ingredients guaifenesin and dextromethorphan.The regulatory agency approved two strengths of Mucinex DM: extended-release guaifenesin 600 mg plus dextromethorphan hydrobromide 30 mg and guaifenesin 1,200 mg plus dextromethorphan hydrobromide 60 mg.Prior to the approval, therapies containing such products were only available via physician-ordered prescription. However, Adams said that Mucinex DM will be available over-the-counter nationally in all retail pharmacies in September.We are confident that Mucinex DM will be a significant addition to the Mucinex family of products and will help us to gain incremental market share in this important consumer category, noted Michael Valentino, Adams chief executive officer.The FDA approved Mucinex (guaifenisin 600 mg or 1,200 mg, extended-release) in July 2002 and, as a result, ordered all other extended-release guaifenesin therapies off the market, effective Dec. 1, 2003.(Source: pharmexec.com, May 2004)


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Posted On: 13 May, 2004
Modified On: 5 December, 2013

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