Amphastar receives FDA OK for generic ProAir HFA

The Food and Drug Administration recently approved Amphastar’s albuterol sulfate inhalation aerosol, previously known as AMP-008. This product is for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease. It is also for the prevention of exercise-induced bronchospasm in patients four years of age and older. 

The product is the generic of Teva Respiratory’s ProAir HFA (albuterol sulfate) Inhalation Aerosol.

"Our first generic inhalation product's approval reflects both our technological and manufacturing ability, said Jack Zhang, CEO and president of Amphastar. “While patients can benefit from increased access to this combination drug product, we are proud to manufacture the finished product in the United States, as our commitment to quality remains our top priority. This approval sets a solid foundation for future growth in developing our other generic inhalation products, highlighting our expertise in developing complex products."

[Read more: Amphastar obtains FDA nod for generic Vasostrict]

The branded and generic albuterol sulfate Inhalation Aerosol products had a market value of  approximately $1.7 billion for the 12 months that ended March 31, 2024, per IQVIA.

Amphastar plans to launch its albuterol sulfate inhalation aerosol in the third quarter of 2024.

[Read more: Amphastar obtains FDA OK for morphine sulfate injection]