ALLEGAN — Perrigo Co. (Nasdaq: PRGO) announced that it has filed with the United States Food and Drug Administration an Abbreviated New Drug Application for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals Inc., the owner of the New Drug Application of its filing.
The ANDA filing involved contributions from both Perrigo and Impax Laboratories Inc. (Nasdaq: IPXL), who will share costs and benefits of this project.
On Jan. 19, Meda Pharmaceuticals filed suit against Perrigo in the United States District Court for the District of New Jersey, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act.
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. Annual sales were approximately $114 million annually, as measured by Wolters Kluwer Health.
Said Perrigo Chairman and CEO Joseph C. Papa: “This filing is another example of our investment in new products and expansion of our 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.”
Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients. Perrigo is the world’s largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.
More at www.perrigo.com.