ALLEGAN, Mich., Dec. 9 /PRNewswire-FirstCall/ -- Perrigo Company today announced that it has filed an Abbreviated New Drug Application for Clobetasol Propionate Topical Spray, 0.05%, a generic form of Clobex(R) Spray.
Perrigo filed its ANDA for Clobetasol Topical Spray, 0.05%, containing a Paragraph IV certification with the U.S. Food & Drug Administration and notified Galderma Laboratories LP, the New Drug Application holder for Clobex(R) Spray, and Dermalogix Partners, Inc., the owner of the patent in suit, of its filing. On December 4, 2009, Galderma filed suit alleging patent infringement in the United States District Court for the Northern District of Texas to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates the process under the Hatch-Waxman Act.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. The Company is the world’s largest manufacturer of OTC pharmaceutical products for the store brand market. The Company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico and the United Kingdom. Visit Perrigo on the Internet (http://www.perrigo.com).
Perrigo Company