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Perrigo: FDA approves generic version of Astepro nasal spray for seasonal allergies

The FDA has approved an abbreviated new drug application for azelastine hydrochloride nasal spray for treating symptoms caused by seasonal allergies or environmental irritants, Perrigo Co. recently announced.

Perrigo and Impax Laboratories contributed to the application for the generic version of Astepro nasal spray (0.15%; Meda Pharmaceuticals), a prescription medicine approved for patients aged 12 years or older, according to a press release. Perrigo reported it has begun shipping the product, with costs and benefits to be shared by both companies.

“This approval is another example of our investment in new products and expansion of our extended topical product portfolio,” Joseph C. Papa, chairman and chief executive officer of Perrigo, said in a press release. “We are pleased to be the partner of choice with Impax on this important product opportunity.”

“Perrigo and Impax continue to be in first to file Hatch-Waxman patent litigation with Meda Pharmaceuticals in the US District Court for the District of New Jersey,” the release stated.