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FDA Approves Reintroduction of OTC Primatene Mist

By January 28, 2019 No Comments

On November 7, 2018, FDA’s CDER approved a new version of Primatene Mist as the only OTC metered-dose inhaler. Primatene is for the temporary relief of mild, intermittent asthma symptoms in consumers ages 12 and up. The original Primatene Mist was discontinued in 2011 because of a ban on the inhaler’s ozone-depleting propellant. That version had been marketed for about half a century. The new version contains a new propellant.

PEGUS was privileged to support Amphastar and play a small role in helping to get this product back on the market. We provided consulting on the consumer labeling as well as label comprehension and human factors studies in support of the approval.

We congratulate Amphastar on its success in getting Primatene Mist approved once again for OTC sale. The reintroduction of Primatene Mist will be welcomed by many former and new users of the product.