Perrigo (PRGO) Files Abbreviated NDA for Generic Clobex Spray; Announces Galderma Lawsuit
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Perrigo Company (NASDAQ: PRGO) today announced that it has filed an Abbreviated New Drug Application for Clobetasol Propionate Topical Spray, 0.05%, a generic form of Clobex Spray.
Clobex (clobetasol propionate) spray is indicated for the treatment of moderate to severe plaque psoriasis, and has estimated brand sales at retail of approximately $55 million annually.
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 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.
Clobex (clobetasol propionate) spray is indicated for the treatment of moderate to severe plaque psoriasis, and has estimated brand sales at retail of approximately $55 million annually.
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 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.
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