FDA panel advises against Merck’s Oxytrol patch Rx-to-OTC switch application
SILVER SPRING, Md. — The Food and Drug Administration’s Nonprescription Drugs Advisory Committee on Friday voted against Merck’s application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor’s intervention.
The committee voted five in favor and six opposed, also citing concerns that men might inappropriately choose to use the product as well.
Panelists opposed to the switch suggested that consumers would have a difficult time self-diagnosing an overactive bladder, as symptoms are similar to those of a number of more serious conditions like bladder malignancy or diabetes.
Proponents of the switch argued that women with overactive bladders may go years before consulting a physician and that an OTC option might encourage therapy sooner.
The Drug Facts label of the proposed OTC Oxytrol patch included a warning that use should be restricted to two weeks if it doesn’t work.
The FDA is expected to issue a decision on the switch application in January 2013.
Family Dollar expands product selections in anticipation of being the one-stop value shop for the holidays
MATTHEWS, N.C. — Family Dollar on Thursday announced it is expanding its holiday selection to include hundreds of toys and gifts retailing for $10 or less.
"We know our customers look to Family Dollar to help them celebrate the holidays," stated Michael Bloom, Family Dollar president and COO. "This year, we are proud to offer an expanded selection of items to make this holiday season even more memorable and budget-friendly."
The toy lineup will include Hot Wheels, Fisher-Price and Disney, along with trendy toy favorites like Kenya, Monster High, Angry Birds, The Avengers and Brave. Family Dollar will be offering a 10% discount for every $100 spent on toys, the dollar store retailer announced.
In addition to an increased seasonal assortment, Family Dollar has expanded its health and wellness, food and household departments to better serve customers’ everyday needs.
"Our goal is to make holiday shopping convenient and affordable for all of our customers," Bloom said. "With Family Dollar’s small format stores and newly re-designed layout, customers will find everything they need quickly and easily, in a fun and festive shopping environment."
Blistex launches two new lip balms as cold front advances through Northeast
OAK BROOK, Ill. — Blistex on Thursday announced the launch of Moisture Melt and Simple and Sensitive lip balms. Moisture Melt features suspended soft beads of aloe and shea butter, while Blistex Simple and Sensitive contains six essential ingredients to provide moisturization without irritation from added dyes or fragrances.
"Moisturization is key to achieving healthy lips year-round, and especially throughout the winter months," stated Charles Zugerman, associate professor of clinical dermatology at the Northwestern University Feinberg School of Medicine. "Moisture Melt and Simple and Sensitive will keep lips hydrated while delivering conditioning benefits to smooth and soften lips."
Blistex Moisture Melt’s shea butter and aloe-enriched soft beads are suspended in the formula and melt into lips for an added moisturizing boost and long-lasting resistance to dryness. The beneficial conditioning effects of natural shea butter and aloe are well-established, Blistex stated. Blistex Moisture Melt is offered in a tube form to deliver the formula at an expected retail price between $1.59 and $2.49.