FDA approves generic albuterol inhaler to mitigate shortages during pandemic

 | Post date: 2020/07/8 | 
On April 8, FDA, recognizing the increased demand for albuterol products during the novel coronavirus pandemic, approved the first generic albuterol inhaler. The albuterol sulfate metered-dose inhaler, 90 mcg/inhalation (Cipla Ltd) is the first AB-rated generic therapeutic equivalent version of Merck’s Proventil HFA and the first generic metered-dose inhaler to be approved in almost 2 decades. The generic inhaler is used to treat or prevent bronchospasm in patients ages 4 years and older who have reversible obstructive airway disease and to prevent exercise-induced bronchospasm in this age group.

Addressing shortages

According to the American College of Allergy, Asthma, and Immunology (ACAAI), certain areas of the country are experiencing shortages of albuterol inhalers because of their increased use in hospitals for patients with COVID-19. These shortages could have implications for the more than 26 million people in the United States who have asthma, of which 7 million are children.
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“FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, MD. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”
According to allergist Michael Blaiss, MD, ACAAI executive medical director, the organization learned of possible shortages about a month ago. “With the introduction of this inhaler, we have a generic product to add to the supply,” Blaiss said in a statement to patients on ACAAI’s website. “While shortages may not be occurring in every part of the country, we want patients to know they may now have additional options if they are having an issue getting their medicine.”
ACAAI has developed recommendations for patients with asthma who are having difficulties accessing inhalers (see sidebar).

Dosage and administration

The recommended dosage for adults and children ages 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.
Each actuation delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece.
Patients should prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four test sprays into the air, away from the face.

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