The FDA approved an abbreviated new drug application (ANDA 214531) for Albuterol Sulfate Inhalation Solution, 0.63 mg (base)/3 mL and 1.25 mg (base)/3 mL unit-dose vials for the relief of bronchospasm in patients 2 to 12 years of age with asthma.
The approval was granted to the RiteDose Corp.
“The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public,” the agency said in a news release.
According to the FDA, side effects of albuterol sulfate inhalation solution include asthma exacerbation, otitis media (middle ear infection), chest pain, and bronchitis.
More information is available on the FDA website.