The FDA approved Amphastar’s abbreviated new drug application for its albuterol sulfate inhalation aerosol, a generic for Teva’s ProAir HFA.
RT’s Three Key Takeaways:
- Amphastar Pharmaceuticals received FDA approval for its abbreviated new drug application for a generic version of the albuterol sulfate inhalation aerosol, previously known as AMP-008.
- The FDA determined that Amphastar’s generic albuterol sulfate inhalation aerosol is bioequivalent and therapeutically equivalent to Teva’s branded ProAir HFA albuterol sulfate inhalation aerosol product.
- This represents Amphastar’s first generic inhalation product approval, which the company sees as validating its technology and manufacturing capabilities for developing complex drug products. Amphastar plans to launch the generic albuterol inhaler in the U.S. market in the third quarter of 2024.
Amphastar Pharmaceuticals Inc announced that the US Food and Drug Administration (FDA) has granted approval for the company’s abbreviated new drug application for albuterol sulfate inhalation aerosol, previously known as AMP-008.
This product is for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four years of age and older.
The FDA determined that Amphastar’s albuterol is bioequivalent and therapeutically equivalent to Teva Respiratory LLC’s ProAir HFA (albuterol sulfate) inhalation aerosol.
“Our first generic inhalation product’s approval reflects both our technological and manufacturing ability. 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,” says Amphastar’s CEO and president Dr Jack Zhang, in a release. “This approval sets a solid foundation for future growth in developing our other generic inhalation products, highlighting our expertise in developing complex products.”
Amphastar plans to launch its albuterol sulfate inhalation aerosol in the third quarter of 2024.
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