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news.Ireland-based Perrigo Company has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%).
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The ANDA involved contributions from both Perrigo and Impax Laboratories, who will share certain costs and benefits of Astepro Nasal Spray.
The spray is a prescription medicine for people 12 years of age and older and is approved for the treatment of nasal symptoms caused by seasonal allergies or environmental irritants.
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 OTC firm has already initiated shipment of the product to its customers.
Perrigo chairman and CEO Joseph Papa said the approval is another example of the company’s investment in new products and expansion of its 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 healthcare more affordable for our customers," Papa said.
Impax president of Global Pharmaceuticals Division Carole Ben-Maimon said, "We are excited to collaborate with Perrigo on this product as we continue to execute our strategy of diversifying our product base."
Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription drugs, nutritional products and active pharmaceutical ingredients (API).
The company also receives royalties from Multiple Sclerosis drug Tysabri.