Approve Drug for OTC Use in the USA for 34+ Million who Suffer Respiratory Issues

The Issue

Ambroxol can drastically improve quality of life for at least tens of millions of Americans (and Canadians). For common cold and cough it could benefit 100M+. As someone who struggles with respiratory issues, I understand the importance of having effective and safe medication readily available. Ambroxol, a superior over-the-counter (OTC) cough and cold medicine, has also been used around the world for a wide range of issues including emphysema, chronic bronchitis and COPD since the 1970s. Recently it has also been used in the treatment of COVID-19. Ambroxol has a successful track record of high efficacy and low side effects. Despite this, it is yet to receive FDA approval for use in the United States.

Many studies and organizations have validated Ambroxol’s efficacy and safety, including the European Journal of Medical Research.

Yet despite these endorsements from reputable health organizations worldwide, U.S citizens are being denied access to this essential medicine. This petition seeks to change that.

We urge the FDA to review their stance on Ambroxol and consider approving it for over-the-counter use in America. By doing so they would be improving access to an effective treatment option for millions suffering from respiratory conditions nationwide. Please sign this petition if you believe everyone deserves access to safe and effective medication like Ambroxol.

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The Issue

Ambroxol can drastically improve quality of life for at least tens of millions of Americans (and Canadians). For common cold and cough it could benefit 100M+. As someone who struggles with respiratory issues, I understand the importance of having effective and safe medication readily available. Ambroxol, a superior over-the-counter (OTC) cough and cold medicine, has also been used around the world for a wide range of issues including emphysema, chronic bronchitis and COPD since the 1970s. Recently it has also been used in the treatment of COVID-19. Ambroxol has a successful track record of high efficacy and low side effects. Despite this, it is yet to receive FDA approval for use in the United States.

Many studies and organizations have validated Ambroxol’s efficacy and safety, including the European Journal of Medical Research.

Yet despite these endorsements from reputable health organizations worldwide, U.S citizens are being denied access to this essential medicine. This petition seeks to change that.

We urge the FDA to review their stance on Ambroxol and consider approving it for over-the-counter use in America. By doing so they would be improving access to an effective treatment option for millions suffering from respiratory conditions nationwide. Please sign this petition if you believe everyone deserves access to safe and effective medication like Ambroxol.

The Decision Makers

Janet Woodcock, M.D.
FDA Director, Center for Drug Evaluation & Research
Robert M. Califf, M.D.
Robert M. Califf, M.D.
FDA Administrator

Supporter Voices

Petition Updates