The FDA approved an abbreviated new drug application (ANDA 214531) for inhaled albuterol sulfate 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.
Inhaled Albuterol Sulfate
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Go To Source For Respiratory Therapy Coverage RT delivers in-depth coverage of the clinical, regulatory, and technology landscape for respiratory therapy—and reaches more than 28,000 key decision-makers and influencers. As one of healthcare’s most important data companies, we facilitate the rapid adoption of medical devices and practice management tools into the industry. Go To Source For Respiratory Therapy Coverage RT delivers in-depth coverage of the clinical, regulatory, and technology landscape for respiratory therapy—and reaches more than 28,000 key decision-makers and influencers. As one of healthcare’s most important data companies, we facilitate the rapid adoption of medical devices and practice management tools into the industry.
