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FDA approves Perrigo’s azelastine nasal spray

Perrigo has announced that it has begun shipping its generic version of Astepro azelastine nasal spray after the ANDA it submitted in partnership with Impax Laboratories received final approval from the FDA. In January 2012, after the two companies filed the ANDA, Astepro maker Meda Pharmaceuticals filed suit for patent infringement in US District Court. According to the Perrigo press release, that litigation is ongoing.

Perrigo Chairman and CEO Joseph C. Papa said, “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 healthcare more affordable for our customers.”

Impax President of the Global Pharmaceuticals Division Carole Ben-Maimon added, “We are excited to collaborate with Perrigo on this product as we continue to execute our strategy of diversifying our product base.”

Read the Perrigo press release.

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published on May 12, 2014

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