Perrigo Announces FDA Tentative Approval For Ibuprofen PM
Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Ibuprofen and Diphenhydramine Citrate Tablets, 200/38 mg.
The national brand's exclusivity ends prior to the end of the calendar year.
The product will be marketed under store brand labels and is comparable to Wyeth Consumer Healthcare's Advil(R) PM tablets, 200/38 mg, indicated as a pain reliever (NSAID)/nighttime sleep-aid. Estimated brand sales for the product for the last 12 months ending September 28, 2008 were $70 million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This is another example of Perrigo's investment in new products making quality healthcare more affordable to American consumers. This is an important addition to our portfolio of products that saves the consumer of our OTC healthcare products approximately $1 billion annually when compared to the higher priced national brands."