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news.Perrigo Company has filed an abbreviated new drug application (ANDA) for azelastine hydrochloride nasal spray (0.15%) with the US Food and Drug Administration (FDA).
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The ANDA filing involved contributions from both Perrigo and Impax who will share costs and benefits of this project.
Astepro Nasal Spray is a prescription medicine for people 12 years of age and older and is approved to treat nasal symptoms caused by seasonal allergies or environmental irritants.
The company has notified Meda Pharmaceuticals, the owner of the New Drug Application (NDA) of its filing.
Perrigo chairman and CEO Joseph Papa said this filing is another example of their investment in new products and expansion of the extended topical product portfolio.
"We are pleased to partner with Impax on this important product opportunity. As always, Perrigo is committed to making quality healthcare more affordable for our customers," Papa added.