The US FDA has approved the first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol. The drug is approved to treat or prevent bronchospasm in patients four and older with reversible obstructive airway disease, and to prevent exercise-induced bronchospasm in patients four and older. The FDA granted approval to Perrigo Pharmaceutical Co.
“This is a significant technical achievement for both parties, as it is the first generic Metered-Dose Inhaler to be approved by the FDA in over twenty years,” Jonathan Arnold, president, Oral and Specialty Delivery at Catalent, a partner company of Perrigo Pharma, said in a press release.
“Today’s approval of the first generic drug product for one of the most commonly used rescue inhalers in the US is part of our longstanding commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market,” said FDA Commissioner Stephen M. Hahn, MD.
The most common side effects associated with Albuterol Sulfate Inhalation Aerosol are headache, rapid heart rate (tachycardia), pain, dizziness, sore throat (pharyngitis), rhinitis, chest pain, palpitations, tremor and nervousness.
Image credit: Perrigo Pharmaceuticals