{"id":10700,"date":"2020-04-14T10:00:25","date_gmt":"2020-04-14T14:00:25","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=10700"},"modified":"2020-10-12T15:10:30","modified_gmt":"2020-10-12T19:10:30","slug":"fda-approves-proventil-generic","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-approves-proventil-generic\/","title":{"rendered":"FDA approves first generic of Proventil HFA"},"content":{"rendered":"

The U.S. Food and Drug Administration (FDA) granted approval to Cipla Limited to manufacture the first generic version of Proventil HFA (<\/span>albuterol sulfate<\/span><\/a>) metered-dose inhaler, 90 mcg\/inhalation.<\/span><\/p>\n

Merck<\/span>, the manufacturer of ProAir, released an authorized generic of ProAir in April 2019, supplied and distributed through one of <\/span>Endo International\u2019s<\/span><\/a> operating companies, Par Pharmaceuticals. This new generic version is the first copy of the original formulation, not produced by Merck. Meaning, it\u2019s adding new competition to the market, which should help to decrease price.\u00a0<\/span><\/p>\n

What is Proventil generic?<\/span><\/h2>\n

This particular type of inhaler, sometimes referred to as a rescue inhaler, is intended to be used to prevent or treat bronchospasm in people aged 4 years and older who have reversible obstructive airway disease. It can also be used for the prevention of exercise-induced bronchospasm. <\/span>Approximately 25 million people<\/span><\/a>, including almost 7 million children, in the United States have asthma, according to the Centers for Disease Control and Prevention (CDC).<\/span><\/p>\n

ProAir HFA (albuterol inhaler) and Proventil HFA (albuterol inhaler) are among the most commonly used albuterol sulfate versions of short-acting bronchodilators on the market. Others include <\/span>Ventolin HFA<\/span><\/a> (albuterol inhaler) and AccuNeb (albuterol nebulizer solution).\u00a0<\/span><\/p>\n

What are the side effects of Proventil HFA generic?<\/span><\/h2>\n

The most common side effects for this type of medication include rhinitis, nausea, vomiting, rapid heart rate, tremor, nervousness, and upper respiratory tract infection, according to the FDA.<\/span><\/p>\n

The benefits of Proventil HFA generic<\/span><\/h2>\n

This approval comes just a few weeks after the FDA approved another generic albuterol inhaler. The FDA gave approval to Perrigo Pharmaceutical Company to start manufacturing the first generic of <\/span>ProAir HFA<\/span><\/a> (albuterol sulfate) inhalation aerosol<\/span> in late February<\/span><\/a>.<\/span><\/p>\n

Generally speaking, the release of another generic form of albuterol is good news for people who need this kind of medication, according to allergist J. Allen Meadows, MD, president of the American College of Allergy, Asthma and Immunology (ACAAI).<\/span><\/p>\n

\u201cIt increases the supply and decreases the cost some, modestly,\u201d Dr. Meadows says.<\/span><\/p>\n

A time of increased demand<\/span><\/h3>\n

According to FDA Commissioner Stephen M. Hahn, MD, there\u2019s already a growing demand for this type of product.<\/span><\/p>\n

\u00a0<\/span>\u201cThe FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,\u201d Dr. Hahn said in a<\/span> statement<\/span><\/a> announcing the approval on April 8. \u201cWe remain deeply committed to facilitating access to medical products to help address critical needs of the American public.\u201d<\/span><\/p>\n

Several weeks ago, the ACAAI released a statement acknowledging shortages of albuterol inhalers in certain parts of the country, due in part to an increased use of inhalers for hospitalized patients with <\/span>COVID-19 infections<\/span><\/a>. Some hospitals were curtailing the use of nebulizers out of concerns that they could spread the virus through the air.<\/span><\/p>\n

But the ACAAI reminded people not to panic and not to worry about stocking up, as one canister of albuterol should last for months. According to Dr. Meadows, one rescue inhaler should last six to 18 months. If you\u2019re using your rescue inhaler up sooner, you may not be <\/span>controlling your asthma<\/span><\/a> well enough. In that case, you may need to speak with your healthcare provider about adjusting or changing the prevention medication that you\u2019re taking.<\/span><\/p>\n

However, some people may still worry about shortages of albuterol rescue inhalers, so the news of another albuterol product hitting the market may be reassuring to them, says Dr. Meadows.<\/span><\/p>\n

\u201cWe should have plenty\u2014don\u2019t worry,\u201d he says.<\/span><\/p>\n

When will Proventil generic be available?<\/span><\/h2>\n

At present, it\u2019s unclear exactly when the new generic will hit the U.S. market. <\/span>A statement released by Cipra on April 9<\/span><\/a> said, \u201cWe are planning shipments in a staggered manner. We are also ensuring that we do our bit by donating the product in this time of need.\u201d<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

The U.S. Food and Drug Administration (FDA) granted approval to Cipla Limited to manufacture the first generic version of Proventil HFA (albuterol sulfate) metered-dose inhaler, 90 mcg\/inhalation. Merck, the manufacturer of ProAir, released an authorized generic of ProAir in April 2019, supplied and distributed through one of Endo International\u2019s operating companies, Par Pharmaceuticals. This new […]<\/p>\n","protected":false},"author":85,"featured_media":6926,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[4141],"coauthors":[9482],"class_list":["post-10700","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-fda-approvals","wpautop"],"acf":[],"yoast_head":"\nFDA approves first Proventil HFA generic<\/title>\n<meta name=\"description\" content=\"The U.S. Food and Drug Administration (FDA) granted approval to Cipla Limited to manufacture the first Proventil HFA generic (albuterol sulfate).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.singlecare.com\/blog\/news\/fda-approves-proventil-generic\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" 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