ALLEGAN — Perrigo Co. (Nasdaq: PRGO) announced that it has filed with the U.S. Food and Drug Administration an Abbreviated New Drug Application for olopatadine hydrochloride nasal spray and that it has notified Alcon Laboratories, the owner of the New Drug Application (NDA). The ANDA filing involved contributions from Perrigo’s partner, Impax Laboratories, Inc. (Nasdaq: IPXL), who will share costs and benefits of this project.
On Oct. 14, Alcon Labs filed suit against Perrigo in the United States District Court for the Northern District of Texas, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act.
Patanase (olopatadine hydrochloride) nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children six years of age and older. Annual sales were approximately $91 million as measured by Wolters Kluwer Health.
Perrigo’s Chairman and CEO Joseph C. Papa stated, “This filing is another example of our investment in new products and expansion of our product portfolio. As always, Perrigo is committed to making quality healthcare more affordable for our customers.”
Impax’s President and CEO Larry Hsu stated, “We are excited to collaborate with Perrigo on this product as we continue to execute our strategy of diversifying our product base.”
About Perrigo Company
Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients. The company 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.