The Medical Letter on Drugs and Therapeutics
FROM
ISSUE 1564
ISSUE 1564
January 28, 2019
OTC Primatene Mist Returns
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January 28, 2019 (Issue: 1564)
The FDA has approved over-the-counter (OTC) sale
of inhaled epinephrine (Primatene Mist – Amphastar),
a nonselective alpha and beta agonist, for temporary
relief of mild symptoms of intermittent asthma in
patients ≥12 years old who have been diagnosed with
mild intermittent asthma by a healthcare professional.
The original version of Primatene Mist, which was
approved by the FDA in 1967, was removed from the
market in 2011 because the metered-dose inhaler (MDI)
contained ozone-depleting chlorofluorocarbon (CFC)
propellants; the new MDI contains hydrofluoroalkane
(HFA) propellants.
... more
- FDA. Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma. Available at: www.fda.gov. Accessed January 17, 2019.
- Drugs for asthma. Med Lett Drugs Ther 2017; 59:139.
- Asthma and Allergy Network. FDA decision to OK Primatene Mist endangers asthma patients. Available at: www. allergyasthmanetwork.org. Accesssed January 17, 2019.
- Cost at www.cvs.com and www.walgreens.com.
- Comparison table: some inhaled drugs for treatment of asthma. Med Lett Drugs Ther 2017; 59:e146. Available at: http://medicalletter.org/TML-article-1528b.

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Title: OTC Primatene Mist Returns
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