Primatene Mist gets OTC reintroduction
Amphastar Pharmaceuticals is bringing its Primatene Mist back to OTC aisles. The Food and Drug Administration approved the product on Wednesday, making it the only agency-cleared nonprescription asthma inhaler in the United States. It is indicated to temporarily relieve mild symptoms of asthma in patients 12 years old and older.
The metered-dose inhaler had previously been taken off the market because it contained chlorofluorocarbon propellants. The new CFC-free version uses hydrofluoroalkane propellants and uses the same active ingredient, epinephrine, as the original Primatene Mist. It also features a built-in spray indicator and a metal canister that replaces the glass container used in the original Primatene Mist.
“We are very happy to have received FDA approval for Primatene Mist and are proud to bring this important product back to the over-the-counter market in the United States,” said Amphaster CEO Jack Zhang. “We are grateful to the FDA team for working closely with us to make this approval possible, recognizing the important role of OTC bronchodilator drugs such as Primatene Mist.”
FDA director Scott Gottlieb and Center for Drug Evaluation and Research director Janet Woodcock issued a joint statement Thursday, noting that the product comes with updated instructions, is not meant to replace a patient’s current treatment, nor meant to treat anything other than mild asthma, and should be used in consultation with a physician.
“The product is appropriate for mild symptoms of intermittent asthma, however, even patients with mild asthma can have severe exacerbations — so it’s still important to consult a healthcare provider about appropriate care and have their condition reassessed,” Gottlieb and Woodcock said. “And, of course, all patients who experience severe exacerbations should go to the emergency room right away.”
Amphastar said that Primatene Mist would be available in major drug stores in the United States starting in early 2019.
The metered-dose inhaler had previously been taken off the market because it contained chlorofluorocarbon propellants. The new CFC-free version uses hydrofluoroalkane propellants and uses the same active ingredient, epinephrine, as the original Primatene Mist. It also features a built-in spray indicator and a metal canister that replaces the glass container used in the original Primatene Mist.
“We are very happy to have received FDA approval for Primatene Mist and are proud to bring this important product back to the over-the-counter market in the United States,” said Amphaster CEO Jack Zhang. “We are grateful to the FDA team for working closely with us to make this approval possible, recognizing the important role of OTC bronchodilator drugs such as Primatene Mist.”
FDA director Scott Gottlieb and Center for Drug Evaluation and Research director Janet Woodcock issued a joint statement Thursday, noting that the product comes with updated instructions, is not meant to replace a patient’s current treatment, nor meant to treat anything other than mild asthma, and should be used in consultation with a physician.
“The product is appropriate for mild symptoms of intermittent asthma, however, even patients with mild asthma can have severe exacerbations — so it’s still important to consult a healthcare provider about appropriate care and have their condition reassessed,” Gottlieb and Woodcock said. “And, of course, all patients who experience severe exacerbations should go to the emergency room right away.”
Amphastar said that Primatene Mist would be available in major drug stores in the United States starting in early 2019.