The US Food and Drug Administration has approved Perrigo Company's 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 cough/cold/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.
Perrigo's chairman, president and CEO Joseph C Papa stated, "This approval strengthens our leading store brand position and highlights our commitment to bringing new products to the market."
From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients (API). 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 logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia.