Perrigo Announces FDA Final Approval for Generic Version of Vanosï¿½ Fluocinonide Cream 0.1% Perrigo Company
By a News Reporter-Staff News Editor at Health & Medicine Week -- Perrigo Company (NYSE: PRGO; TASE) announced that it has received final approval 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 (see also Perrigo Company).
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."
>From its beginnings as a packager of generic home remedies in 1887, Perrigo Company, based in Allegan, Michigan, has grown to become 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. Perrigo's mission is to offer uncompromised "quality, affordable healthcare products", and it does so across a wide variety of product categories primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as certain other markets throughout the world, including Canada, China and Latin America. Visit Perrigo on the Internet (http://www.perrigo.com).
Keywords for this news article include: Generics, FDA Actions, Legal Issues, Perrigo Company.
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