FDA rules active in MiraLax can only be marketed as OTC
The Food and Drug Administration earlier this month effectively eliminated any Rx-only competition to Bayer’s OTC laxative MiraLax (polyethylene glycol 3350).
The active ingredient in MiraLax had been approved for sale without a prescription nearly 12 years ago, but since that time, some manufacturers of products containing the identical ingredient for the same use, refused to withdraw their Rx-labeled products from the market and to re-apply for OTC status, as is required under the Federal Food, Drug, and Cosmetic Act.
“Consumers today are more empowered than ever to take their health into their own hands with an increasing array of choice and access to safe and effective over-the-counter medicines. The order confirms the same ingredient, absent a meaningful difference (such as the use or strength), may not be prescription and OTC at the same time,” the Consumer Healthcare Products Association stated in a release issued earlier this week. “This week’s FDA action resolves any remaining questions on this matter and reminds manufacturers to respect the formal procedures underpinning the Rx-to-OTC switch process and to work cooperatively to honor these regulations to prevent consumer confusion in the marketplace.”
The ruling may drive more consumers in search of the OTC laxative to the retail pharmacy. For the 52 weeks ended Nov. 5, 2017, sales of MiraLax across total U.S. multi-outlets totaled $205.2 million, up 3.3%.
FDA’s decision impacts five manufacturers with PEG 3350 ANDA approvals, including Kremers Urban Pharmaceuticals, Breckenridge Pharmaceutical, Nexgen Pharma, Paddock Laboratories and Teva Pharmaceutical.
Vicks ZzzQuil rounds out sleep portfolio with natural line
Procter & Gamble entered the natural sleep arena Wednesday with the launch of Vicks ZzzQuil Pure Zzzs Melatonin Gummies.
“There is no ‘one-size-fits-all’ approach to overcome sleeplessness, and since consumers have different needs at different times, we are constantly looking for ways to offer real sleep innovations to meet a variety of those needs,” Phil McWaters, brand franchise director, North America Vicks, said. “Vicks ZzzQuil Pure Zzzs Melatonin Gummies are meant to answer the need for a drug-free option that helps people fall asleep naturally and wake refreshed.”
Roughly two-thirds (67%) of Americans said they have trouble falling asleep at least once a month, and nearly half (47%) reported that they experience this trouble at least once a week, according to a ZzzQuil consumer survey. Additionally, 4-in-5 consumers who tried a sleep aid reported that it helped them fall asleep more easily and stay asleep.
Several suppliers in the category reported that sleep-deprived consumers want something that works quickly, keeps them sleeping through the night and leaves them refreshed and ready to take on the new day, according to a sleep aid report published by the Drug Store News Group in February.
Vicks ZzzQuil Pure Zzzs Melatonin Gummies contain a unique botanical blend of lavender, chamomile, valerian root and lemon balm that will appeal to the growing number of consumers who are in search of non-medicinal sleep aids. The wildberry vanilla flavored gummies are drug-free, vegan, vegetarian and free of artificial flavors, gluten, lactose and gelatin.
In addition to the gummies, the Cincinnati-based supplier has also launched Vicks Pure Zzzs Soothing Aromatherapy Balm, which is formulated with a blend of essential oils like lavender and chamomile.
Contour Next expands diabetes reach through UnitedHealthcare
Ascensia Diabetes Care’s Contour Next blood glucose monitor is now available to patients covered by UnitedHealthcare commercial plans. Prior to this change, UnitedHealthcare members were unable to obtain the Contour Next portfolio of meters and test strips, unless a Prior Authorization was approved by the plan.
“We are working together with UnitedHealthcare to help their members with diabetes obtain the highly-accurate Contour Next test strips and meters so that they can effectively manage their diabetes,” said Robert Schumm, vice president and managing director of Ascensia Diabetes Care US, which operates out of Basel, Switzerland. “This change will give more people the opportunity to access these products, and at a reasonable cost.”
Specifically, individuals enrolled in UnitedHealthcare commercial plans will have access to these products through their pharmacy benefit at a Tier 2 copay level.
Contour Next can connect mobile devices via Bluetooth to make management easier for patients, the company said, noting that its expanded availability will be a boon for patients manging their diabetes. The Contour Diabetes app collects, stores and analyzes patient blood glucose measurements received from the meter. The company said this data can be used to identify patterns and trends that could help patients better understand how their daily activities affect their blood glucose.
The system includes a smartLIGHT that to provides instant feedback on results, reminders and alerts, as well as a logbook where patients can record meals, activities and medication. Patients also can set up an online account to manage and store their data, as well as have a PDF summary emailed to their caregiver or healthcare professional.