ALLEGAN, Mich., April 24 /PRNewswire-FirstCall/ -- The Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter (OTC) Nicotine Polacrilex Gum USP, 2 mg (base) and 4 mg (base) (Orange, Coated).
The FDA has determined the product to be bioequivalent to the reference listed drug, GlaxoSmithKline's Nicorette(R) Gum, 2 mg (base) and 4 mg (base), which is an aid to smoking cessation. "This approval of orange-flavored, coated nicotine gum extends our leading store brand position. Our expanded range of smoking cessation products also includes coated mint-flavored gum, coated fruit-flavored gum, uncoated gum and lozenges," said Joseph C. Papa, Perrigo's Chairman and CEO. The overall market for OTC nicotine gum and lozenge products is estimated at approximately $750 million annually at all retail outlets.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of manufacturing facilities are the United States, Israel, Mexico and the United Kingdom. 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 created thereby.
These statements relate to fut
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