Perrigo Co. plc received final approval from the Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%), an allergy medication.


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Perrigo begins shipping generic Astepro nasal spray

May 12th, 2014

DUBLIN, Ireland – Perrigo Co. plc received final approval from the Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%), an allergy medication.

Perrigo said Monday that it has started shipping the product, a generic version of Meda Pharmaceuticals Inc.'s Astepro Nasal Spray.

According to Perrigo, the ANDA involved contributions from both Perrigo and Impax Laboratories Inc, which will share certain costs and benefits of this product. Perrigo and Impax continue to be in first to file Hatch Waxman patent litigation with Meda in the U.S. District Court for the District of New Jersey, Perrigo added.

"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," stated Perrigo chairman and chief executive officer Joseph Papa.

A prescription medicine for people age 12 and older, Astepro Nasal Spray is indicated for the treatment of nasal symptoms caused by seasonal allergies or environmental irritants. Annual sales are approximately $97 million, based on Symphony Health Solutions data cited by Perrigo.

"We are excited to collaborate with Perrigo on this product as we continue to execute our strategy of diversifying our product base," commented Carole Ben-Maimon, president of Impax's global pharmaceuticals division.

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