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Perrigo Announces Launch of Authorized Generic Version of Acetadote, Plus Infant Formulas

ALLEGAN -- Perrigo Co. (Nasdaq: PRGO) Monday announced that it has made initial shipments distributing Cumberland Pharmaceuticals Inc.'s authorized generic form of Acetadote (acetylcysteine) injection.

Last Nov. 13, Perrigo announced that it and Cumberland had successfully settled their patent litigation. In addition, Perrigo secured the right to be a distributor should Cumberland elect to launch an authorized generic acetylcysteine injection product.

Acetadote (acetylcysteine) injection, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury and has annual sales of approximately $41 million, as measured by Symphony Health Solutions.

"This is another example of Perrigo's commitment to bring new products to market," said Perrigo chairman, president and CEO Joseph C. Papa. "Perrigo continues to deliver on its mission to provide quality, affordable healthcare to consumers."

Perrigo also announced FDA clearance to manufacture three new infant formula products. These new formulas are also compliant with the Codex Alimentarius Commission, established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) to set international food standards, guidelines and codes of practice to protect the health of consumers and ensuring fair trade practices globally.

Perrigo Nutritionals will be producing these FDA-cleared Codex Stage 1 milk-based infant formulas, Codex Stage 2 milk-based infant formula, and Codex Stage 2 milk-based infant formula with ethyl vanillin flavoring, in its ISO 9001:2008 certified infant formula facility in Vermont, U.S.A. Formerly owned by Wyeth and PBM Nutritionals, the facility has been producing infant formula for more than 25 years. Perrigo Nutritionals is the largest supplier of store brand infant formula in the world and currently supplies formulas to customers in 23 countries.

From its beginnings as a packager of generic home remedies in 1887, Perrigo Co., based in Allegan, has grown to become a global provider of over-the-counter and generic prescription pharmaceuticals, nutritional products and active pharmaceutical ingredients  and is the world's largest manufacturer of OTC pharmaceutical products for the store brand market.

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