FDA Approved the First-ever Generic Version of  Proventil HFA Inhaler for Treating Bronchospasm

The U.S. Food and Drug Administration (FDA) has approved the first-ever generic version of the Proventil HFA (albuterol sulfate) Inhaler with 90 mcg/Inhalation, to help the patients of bronchospasm. This inhaler is approved to be used on at least four years of age and older patients who are suffering from an obstructive respiratory disease. Not only it treats this condition but also prevents bronchospasm, mostly initiated by exercise or any moderate physical activity.

Stephen M. Hahn, the Commissioner at FDA said; “The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic. We remain deeply committed to facilitating access to medical products to help address the critical needs of the American public.”

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The National Heart, Lung, and Blood Institute, explains that bronchospasms occur when the surrounding muscles of the respiratory canal are swollen and become tight. It causes these muscles to contract the air passage and makes it narrow. With this condition, doing a mild to moderate exercise or any other physical activity could cause severe symptoms for people who have asthma.

Normally, asthma causes its patients to experience a whistle-like sound during normal breathing. The additional symptoms might also show up like feeling tightness in the chest, difficulty in breathing and constantly coughing. These symptoms especially coughing could be worst at night or when a person wakes up in the morning.

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People of all ages could have asthma and it is not just confined to older people. In most of the cases, it shows up during the childhood of a person and remains forever. Only in the USA, there are at least 26 million patients of asthma and 7 million of these patients are underage kids.

Generally, this inhaler is safe but it might cause reparatory infections, allergic rhinitis, nausea or vomiting in some patients. The U.S. Food and Drug Administration (FDA) is committed to helping the manufacturers for producing generic produces that also include products made of complex combinations and this inhaler is one of those products. It is a drug as well as a device which is why producing such combinational products is trickier than manufacturing medicines.

The Generic Drug User Fee Amendments (GDUFA) is a protocol that allows different companies to follow the FDA guidelines under its pre-Abbreviated New Drug Application (ANDA) program. It is specially designed to facilitate the production of complex products. In addition to that FDA also publishes guidelines explaining the recommendations before submitting an application for a new product.

Last month, the FDA has published a revised version of draft product-specific guidance for this new product “generic albuterol sulfate metered dose inhaler” along with Proventil HFA. FDA urges all applications to be submitted as per guidelines and contain all information to explain if the generic drug-device combinational product is as per the FDA’s standards or not. These standards evaluate the quality of a product as well as its safety level before launching it into the market.

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Despite the treatment options, medical experts are still not sure why some people are more likely to have bronchospasms. Typically, bronchospasms were thought to be a symptom of asthma but research on this condition tells that these are two separate health conditions.

A study from 2014 tells that 8,000 school going kids from France are suffering from bronchospasms induced by exercise. The study concluded that bronchospasms represent another medical condition and not a symptom of asthma. It also discussed that bronchospasms are linked with multiple atopic rhinitis in which a patient develops dryness in the nasal area and post-nasal dripping. Some major symptoms of bronchospasms are difficulty in breathing, persistent cough and chest pain.