FDA approves OTC nicotine gum
CORONA, Calif. Watson Pharmaceuticals on Wednesday announced that its subsidiary Watson Laboratories received approval from the Food and Drug Administration to market its over-the-counter Nicotine Polacrilex Gum USP, coated mint flavor, in the 2-mg and 4-mg strengths.
Nicotine Polacrilex Gum, coated mint flavor, is the generic equivalent of GlaxoSmithKline Consumer Healthcare’s Nicorette fresh mint gum. The market for over-the-counter nicotine gum had annual sales of more than $300 million for the 12 months ending September 2008, according to IRI sales data as provided by Watson. Watson will make the product available to customers in early January 2009.
“The approval of our mint flavored, coated nicotine gum is a significant addition to our line of generic smoking cessation products,” stated Paul Bisaro, Watson president and chief executive officer. “We also have applications pending at FDA for additional flavors and look forward to further enhancing our line of smoking cessation products.”
FDA approves new ibuprofen and diphenhydramine citrate tablets
ALLEGAN, Mich. Perrigo received final approval from the Food and Drug Administration for its abbreviated new drug application of over-the-counter ibuprofen and diphenhydramine citrate tablets, 200/38 mg, the company announced Monday.
Perrigo is expecting to begin product shipments to retailers during the first quarter of 2009.
The product is comparable to Wyeth Consumer Healthcare’s Advil PM tablets, 200/38 mg, indicated as a pain reliever/nighttime sleep-aid. Estimated brand sales for the product for the last 12 months ended Sept. 28 were $70 million, according to data provided by Perrigo.
Integrated Beverage launches Children’s Throat Cooler
FARMINGDALE, N.Y. Integrated Beverage Group recently launched Children’s Throat Cooler, a nonmedicated ready-to-freeze liquid product that helps hydrate and rejuvenate dry throats, the company stated.
Throat Cooler is made with honey and supplemented with vitamin C. The product is recommended for use for children over the age of 2.Available in strawberry and grape flavors, a multi-pack of six pre-portioned single-serve pouches retails for a suggested $3.99.