10:17 AM EDT, 05/22/2024 (MT Newswires) -- Amphastar Pharmaceuticals ( AMPH ) said Wednesday the US Food and Drug Administration has approved its Abbreviated New Drug Application for albuterol sulfate inhalation aerosol to treat bronchospasm in patients four years and older.

An Abbreviated New Drug Application is filed with the FDA to gain approval for marketing a generic drug and requires proof that it is bioequivalent to an already approved brand-name drug, according to the FDA.

The company said the FDA found Amphastar's albuterol sulfate inhalation aerosol to be equivalent to Teva (TEVA) Respiratory's HFA inhalation aerosol product ProAir.

Amphastar said it plans to launch the product in Q3.

Shares of the company were up 4.3% in recent Wednesday trading.

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