Perrigo Company today announced that it has filed an Abbreviated New Drug Application (ANDA) for Fluocinonide Cream 0.1%, a generic version of VANOS(R) Cream 0.1%. The Company believes that it is the first to file an ANDA with a Paragraph IV certification against VANOS(R).
VANOS(R) (fluocinonide) Cream 0.1% is a corticosteroid (steroid hormone) approved to relieve the inflammation and itching caused by certain skin conditions that respond to treatment with corticosteroids in patients 12 years of age or older, and had sales of approximately $27 million for the 12 months ended April 2008, as measured by Wolters Kluwer Health.
Perrigo filed its ANDA for Fluocinonide Cream, 0.1% containing a Paragraph IV Certification with the U.S. Food & Drug Administration and notified Medicis Pharmaceutical Corporation, the listed patent holder of its filing. On June 6, 2008, Medicis filed suit alleging patent infringement in the United States District Court for the Western District of Michigan to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates the patent process under the Hatch-Waxman Act.
(Source:www.pharmalive.com)
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