The company believes that it is the first to file an abbreviated new drug application (ANDA) with a Paragraph IV certification against Vanos.
Perrigo filed its ANDA for Fluocinonide cream, 0.1% containing a Paragraph IV Certification with the FDA and notified Medicis Pharmaceutical, the listed patent holder of its filing.
Vanos (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.