ALLEGAN, Mich., Aug. 19 /PRNewswire-FirstCall/ — Perrigo
Company (Nasdaq: PRGO;TASE) announced its filing with the U.S. Food
and Drug Administration (FDA) for its Abbreviated New Drug
Application (ANDA) for clobetasol propionate shampoo, 0.05%, and
notified Galderma, the listed patent owner.
On August 17, 2010, 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 this product. This action formally initiates
the process under the Hatch-Waxman Act.
The product is substitutable to Galderma’s Clobex® Shampoo,
0.05%, a topical corticosteroid indicated for the treatment of
moderate to severe psoriasis of the scalp. Sales for the brand were
approximately $53 million, according to Wolters Kluwer data for the
twelve months ending June 2010.
Perrigo’s Chairman and CEO Joseph C. Papa stated, “This filing
reflects our razor focused strategy of bringing new extended
topical products to market and making quality healthcare more
affordable for our customers.”
Perrigo Company is a leading global healthcare supplier that
develops, manufactures and distributes OTC and generic prescription
(Rx) pharmaceuticals, infant formulas, nutritional products, active
pharmaceutical ingredients (API) and pharmaceutical and medical
diagnostic products. The Company is the world’s largest store brand
manufacturer of OTC pharmaceutical products and infant formulas.
The Company’s primary markets and locations of manufacturing and
logistics operations are the United States, Israel, Mexico, the
United Kingdom and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).
Note: Certain statements in this press release are
forward-looking statements within the meaning of Section 21E of the
Securities Exchange Act of 1934, as amended, and are subject to the
safe harbor creat