Courtesy of Benzinga.
Perrigo Company (Nasdaq: PRGO) announced that it has filed with the U.S. Food and Drug Administration (FDA) 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 January 19, 2012, 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.
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