FDA’s Nonprescription Drugs Advisory Committee to meet on Oxytrol Rx-to-OTC switch
SILVER SPRING, Md. — According to a Food and Drug Administration post Friday, the FDA’s Nonprescription Drugs Advisory Committee will be meeting Nov. 9 regarding the partial switch application from prescription to over the counter of Oxytrol (oxybutynin transdermal system) submitted by MSD Consumer. The proposed OTC product would be called Oxytrol for Women and would be indicated for the treatment of overactive bladder in women.
The prescription form of Oxytrol is licensed by Watson Pharma.
The data to be discussed will include a summary of the postmarketing experience with the oxybutynin transdermal system, and the results of consumer studies, including label comprehension studies, self-selection studies and an actual use study. The committee will be asked to consider whether the data support the appropriate and safe use of oxybutynin transdermal system by OTC consumers.
According to the U.S. National Library of Medicine, oxybutynin transdermal patches are used to treat an overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate and inability to control urination). Oxybutynin is in a class of medications called anticholinergics. It works by relaxing the bladder muscles to prevent urgent, frequent or uncontrolled urination.
About 17% of women over the age of 18 experience overactive bladder, according to the National Association for Continence. In women between the ages of 20 and 45, the prevalence of overactive bladder was found to be 36.8%.
Overactive bladder occurs about twice as frequently in women as in men and become more prevalent with advanced aging.
"Women with [overactive bladder] are significantly more likely to suffer from other health disorders, such as hypertension, obesity and arthritis, than women without OAB," the NAC added. "Also, [overactive bladder] sufferers are two to three times more likely to regularly experience disturbed sleep, overeating and poor self-esteem, compared with non-OAB sufferers."
Whole Foods launches green gift card program
AUSTIN, Texas — Whole Foods Market has launched two new eco-friendly gift cards, with plans to replace the recycled plastic cards that will be phased out over time.
The new cards — one made of paper and the other of responsibly harvested wood — are certified by the Forest Stewardship Council and have a lower carbon footprint, are reusable, recyclable, compostable and require less energy to be produced.
"We are constantly looking for ways to reduce our environmental impact and further our green mission efforts,” said Chris Jensen, gift card team leader for Whole Foods Market.
The grocer said it will continue to recycle gift cards both from Whole Foods Market and other retailers at its stores. To date, more than 265,000 plastic gift cards have been recycled and kept out of landfills.
Newell Rubbermaid names new CFO
ATLANTA — Newell Rubbermaid has appointed Doug Martin as CFO, succeeding Juan Figuereo.
A 25-year veteran of the company, Martin most recently served as deputy CFO, where he is credited with designing a roadmap for streamlining the cost structure of the company and the global finance function. Prior to that, he held a number of key financial leadership positions, including VP finance for Newell’s consumer business, with financial responsibility for the company’s largest operating group; VP finance of office products, where he helped drive a significant turnaround in the group’s operating performance; and corporate VP — treasurer.
"We are making good early progress in the execution of our growth game plan by taking an aggressive stance toward reducing structural costs and working capital, and increasing brand investment," said Michael Polk, Newell Rubbermaid’s president and CEO. "Doug’s strategic leadership, financial expertise and deep company and industry knowledge will be instrumental to helping us realize our growth ambition."
Juan Figuereo joined Newell Rubbermaid as its CFO in 2009, with a primary focus on strengthening the company’s balance sheet and operating cash flow. With the balance sheet metrics nearly in line with targeted leverage metrics and the company now focused on growth, Figuereo made the decision to step down. He will remain with the company for the next few months in order to ensure a seamless transition.