Perrigo Company has received final approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for fluocinonide cream 0.1%, the generic equivalent to Vanos cream 0.1%. Perrigo was awarded 180-days of generic drug exclusivity as it was the first company to submit an ANDA containing a paragraph IV certification. Perrigo had previously resolved litigation with the brand and has commenced shipment of the product.
Vanos cream 0.1% (fluocinonide cream 0.1%) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older and has estimated annual sales of approximately $107 million.
Perrigo's chairman, president and CEO Joseph C Papa stated, "This is another example of our Rx team's commitment to launching difficult to manufacture topicals, lotions and foams. We are excited to market this product and are dedicated to making quality healthcare more affordable for all patients."
Perrigo Company is a leading global healthcare supplier. The Company develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API) and is the world's largest manufacturer of OTC pharmaceutical products for the store brand market.