Perrigo Company (Nasdaq: PRGO;TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals, Inc., the owner of the New Drug Application (NDA) 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.
Perrigo's Chairman and CEO Joseph C. Papa stated, "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."
Impax's President and CEO Larry Hsu, P.h.D. stated, "We are excited to collaborate with Perrigo on this product as we continue to execute our strategy of diversifying our product base."
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