{"id":50057,"date":"2022-03-22T10:30:32","date_gmt":"2022-03-22T14:30:32","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=50057"},"modified":"2022-06-03T15:34:10","modified_gmt":"2022-06-03T19:34:10","slug":"symbicort-generic-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/symbicort-generic-fda-approval\/","title":{"rendered":"FDA approves first Symbicort generic for asthma and COPD"},"content":{"rendered":"

On Mar. 15, 2022, the <\/span>U.S. Food and Drug Administration (FDA)<\/span><\/a> approved Breyna, the first generic Symbicort, a crucial <\/span>asthma<\/span><\/a> and <\/span>chronic obstructive pulmonary disease<\/span><\/a> (COPD) treatment. It\u2019s another, more affordable option for people with these common respiratory conditions.<\/span><\/p>\n

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

Breyna, also called budesonide and formoterol fumarate dihydrate, <\/span>is a combination medication administered through a metered-dose <\/span>inhaler<\/span><\/a>. <\/span>The new generic <\/span>Symbicort<\/span><\/a> contains an anti-inflammatory <\/span>corticosteroid (budesonide)<\/span><\/a> along with a long-acting <\/span>bronchodilator<\/span><\/a> (formoterol). This combination medication works to reduce the swelling in the respiratory system and to open airways\u2014allowing people with asthma or COPD to breathe easier.\u00a0<\/span><\/p>\n

RELATED: <\/b>COPD vs. asthma<\/b><\/a><\/p>\n

Brand-name Symbicort was previously approved by the FDA for asthma in adults and adolescents 12 years and older in <\/span>2006<\/span><\/a>, for people with COPD in <\/span>2009<\/span><\/a>, and <\/span>more recently<\/span><\/a> for children with asthma between the ages of 6 and 12.\u00a0 The new generic is approved for individuals with asthma aged 6 years and older, and adults with COPD.\u00a0<\/span><\/p>\n

Dosage<\/span><\/h3>\n

While some inhalers are used for acute asthma attacks, Symbicort and the generic are for maintenance use only. \u201cInhaled corticosteroid medications such as budesonide that are combined with formoterol not only help control asthma symptoms but also reduce the risk of severe exacerbations when used as daily maintenance inhalers,\u201d says<\/span> Chet Tharpe<\/span><\/a>, <\/span>MD, dual-certified allergist and immunologist, and medical director at<\/span> Curex<\/span><\/a>.\u00a0<\/span><\/p>\n

Breyna is mea<\/span>nt to be used twice a day, or as directed by a healthcare professional, for the purpose of preventing attacks or an increase in symptoms. <\/span>Like<\/span> Symbicort, the generic come in two strengths (160\/4.5 mcg\/actuation and 80\/4.5 mcg\/actuation).\u00a0\u00a0<\/span><\/p>\n

Side effects<\/span><\/h3>\n

Any drug comes with potential side effects\u2014and often, they don\u2019t affect most people who use the medication. The FDA says common side effects associated with this medication in people with asthma are:<\/span><\/p>\n