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Perrigo gets OK for aplication
ALLEGAN — Perrigo Co. announced this week that it has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for over-the-counter Ibuprofen and Diphenhydramine Citrate tablets. The drug’s national brand’s exclusivity ends prior to the end of this calendar year.
The product will be marketed under store brand labels and is comparable to Wyeth Consumer Healthcare’s Advil PM tablets, used as a pain reliever and nighttime sleep aid. Advil PM’s brand sales for the last 12 months ending Sept. 28 were $70 million, according to Perrigo.
“This is an important addition to our portfolio of products that saves the consumer of our OTC health care products approximately $1 billion annually when compared to the higher priced national brands,” commented Perrigo Chairman and CEO Joseph C. Papa.