{"id":9299,"date":"2020-02-26T14:36:23","date_gmt":"2020-02-26T19:36:23","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=9299"},"modified":"2020-07-10T13:38:51","modified_gmt":"2020-07-10T17:38:51","slug":"proair-hfa-generic-approved","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/proair-hfa-generic-approved\/","title":{"rendered":"FDA approves first ProAir HFA generic"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">The U.S. Food and Drug Administration (FDA) granted Perrigo and its partner Catalent Pharma Solutions approval for the first ProAir HFA generic (albuterol sulfate). The rescue inhaler can treat or prevent bronchospasm with reversible obstructive airway disease and exercise-induced bronchospasm in people aged 4 and older.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Teva, the manufacturer of ProAir, released an authorized generic of ProAir in January 2019. This new AB-rated generic version is the first copy of the original formulation, not produced by Teva. It should drive prices even lower. In other words, people with asthma will soon have a cheaper option to help them breathe more easily.<\/span><\/p>\n<p><a href=\"https:\/\/www.singlecare.com\/prescription\/proair-hfa\"><span style=\"font-weight: 400;\">ProAir<\/span><\/a><span style=\"font-weight: 400;\"> is the most popular rescue inhaler in the U.S. This generic <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/albuterol-sulfate\"><span style=\"font-weight: 400;\">albuterol sulfate<\/span><\/a><span style=\"font-weight: 400;\"> inhalation aerosol product gives an additional choice to the 26 million people in the United States who have asthma, many of whom need to use both a long-term control medicine and a quick-acting medicine, like a rescue inhaler.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Like ProAir HFA, the generic version is a metered dose inhaler that can be used by people with asthma as a quick-acting medication. It\u2019s a type of medicine called a bronchodilator. It provides quick-relief by relaxing muscles in the airways, opening them up for air to flow through. Within just a few minutes of using the inhaler, the medication alleviates symptoms like wheezing, chest tightness, and shortness of breath.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe approval of a generic Proair HFA is a significant achievement!\u201d says Shaili Gandhi, Pharm.D., vice president of formulary operations at SingleCare. \u201cIt is difficult for drug companies to get approval for drugs in complex delivery systems\u2014this is the first generic metered dose inhaler approved in 20 years.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">According to FDA Commissioner Stephen M. Hahn, MD, there\u2019s a reason for the delay. \u201cMetered dose inhalers like these are known as complex generics, which are traditionally harder to copy because of their complex formulation or mode of delivery,\u201d Hahn said in a statement announcing the FDA\u2019s approval on Feb. 24.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The medicine will contain 200 metered inhalations. Dosage amounts may vary, based on the user\u2019s needs. (<\/span><a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021457s036lbl.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">The prescribing information for ProAir HFA<\/span><\/a><span style=\"font-weight: 400;\"> recommends two inhalations every four to six hours or two inhalations 15-30 minutes before exercising.) Healthcare professionals suggest that people who need to use their rescue inhaler more than twice a week discuss their condition with their doctor, as they may need to adjust their long-term control medicines.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If you have asthma and use a rescue inhaler like ProAir HFA, this approval could mean more money in your pocket. \u201cIn the last year, Proair HFA sales were approximately $1.4 billion,\u201d Dr. Gandhi says. \u201cThe generic release will help alleviate the cost burden so many users endure. The release of the generic will be limited at first, but the manufacturing company anticipates a steady supply by the end of the year.\u201d<\/span><\/p>\n<p><a href=\"https:\/\/www.perrigo.com\/press-release\/perrigo-and-catalent-announce-fda-approval-perrigos-ab-rated-generic-version-proairr\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Perrigo and its partner Catalent confirmed in a statement released Feb. 25<\/span><\/a><span style=\"font-weight: 400;\"> that they plan to ramp up production to meet anticipated future demand after an initial limited commercial supply.\u00a0<\/span><span style=\"font-weight: 400;\">Other brand name versions of this type of albuterol inhaler include <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/ventolin-hfa\"><span style=\"font-weight: 400;\">Ventolin HFA<\/span><\/a><span style=\"font-weight: 400;\">, which is manufactured by GlaxoSmithKline, and Proventil HFA, which is manufactured by Merck Sharp &amp; Dohme Corp.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) granted Perrigo and its partner Catalent Pharma Solutions approval for the first ProAir HFA generic (albuterol sulfate). The rescue inhaler can treat or prevent bronchospasm with reversible obstructive airway disease and exercise-induced bronchospasm in people aged 4 and older.\u00a0 Teva, the manufacturer of ProAir, released an authorized generic [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":6927,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[10965,4141],"coauthors":[9482],"class_list":["post-9299","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-asthma","tag-fda-approvals","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>First Proair HFA generic approved by the FDA<\/title>\n<meta name=\"description\" content=\"There is new competition in the rescue inhaler market. 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