Perrigo receives FDA approval for generic Astepro

DUBLIN — Perrigo on Monday announced that it received approval from the Food and Drug Administration for azelastine hydrochloride nasal spray (0.15%), a generic version of Astepro.

The prescription medicine is indicated for people ages 12 years and older and is used to treat nasal symptoms brought on by seasonal allergies or environmental irritants. Annual sales for the drug were approximately $97 million, according to Symphony Health Solutions

"This approval is another example of our investment in new products and expansion of our extended topical product portfolio. We are pleased to be the partner of choice with Impax on this important product opportunity. As always, Perrigo is committed to making quality health care more affordable for our customers," said Joseph C. Papa, Perrigo's chairman and CEO.      

The company's abbreviated new drug application involves contributions from both Perrigo and Impax Labs; the two companies will share certain costs and benefits of the product.


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