ALLEGAN (WWJ) — Perrigo Co. (NYSE: PRGO) announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for cetirizine hydrochloride oral solution USP, 1 mg/mL, bubble gum flavored, the store brand equivalent to Children’s Zyrtec Allergy Syrup, 1 mg/mL, bubble gum flavored.
Perrigo expects to begin shipments of the product during the upcoming cold and flu season.
Children’s Zyrtec Allergy Syrup, 1 mg/mL, bubble gum flavored, (cetirizine hydrochloride oral solution USP, 1 mg/mL, bubble gum flavored) is indicated for Indoor and outdoor allergies in children 2 years of age and older and is part of the overall Zyrtec brand with estimated annual sales of approximately $380 million.
“This approval strengthens our leading store brand position and highlights our commitment to bringing new products to the market,” said Perrigo chairman, president and CEO Joseph C. Papa.
Perrigo also announced that Papa will present at the Stifel Nicolaus Healthcare Conference on Wednesday, Sept. 11 at the Four Seasons Hotel in Boston. Interested parties can access the presentation, which is scheduled to begin at 3:50 p.m. Eastern time, at this link.
From its beginnings as a packager of generic home remedies in 1887, Allegan-based Perrigo has grown into the world’s largset manufacturer of over the counter pharmaceuticals for the store brand market. It develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients. Its primary markets are the United States, Israel, Mexico, the United Kingdom, India, China and Australia.
More at http://www.perrigo.com.