Blog: Sanofi sues FDA to delay publication of OTC Nasacort labeling
WASHINGTON — Sanofi-Aventis has sued the Food and Drug Administration to keep its labeling for OTC Nasacort confidential in an effort to delay store brand competition until after the launch, according to an entry in the FDA Law Blog, the official blog of Hyman, Phelps & McNamara, published Thursday.
Sanofi was not granted three years of product exclusivity with the Nasacort switch. By not releasing official labeling before the OTC debut, generic brand manufacturers will not have the advanced knowledge they need to introduce a private label version of Nasacort at the time of launch.
The FDA is expected to make Nasacort labeling available on its site on Nov. 12.
Coolcore launches flexible ice and compression wraps
PORTSMOUTH, N.H. — Coolcore on Thursday introduced Dr. Cool Recovery-On-The-Go Wraps at www.drcoolrecovery.com. Dr. Cool Recovery-On-The-Go Wraps combine ice and compression in one flexible wrap, the company stated.
"Nothing hurts more than being stuck on the couch when you want to be out enjoying your passions," stated Nick Skally, marketing director for Coolcore. "Dr. Cool wraps provide a convenient, life-friendly recovery option for today’s active, overscheduled consumers."
Designed for weekend warriors, business travelers and hard core sports devotees, Dr. Cool wraps can be used as a dry compression wrap to support and protect various body parts during activities, or frozen to combine cold and compression to reduce swelling and speed recovery mid or post-activity. Users may also use Dr. Cool as a cold compress, by wetting the wrap, rolling and then freezing for 20 minutes.
The chemical-free wrap is available in three sizes and can be wrapped on any body part that needs cold therapy or simply a compression wrap to support ailments. The large is $34.99, medium is $29.99 and small is $24.99.
For 2013, Dr. Cool will team up with Walt Disney World to support the runDisney events including the Wine & Dine Half Marathon on Nov. 9 and 10 and the Walt Disney World marathon on Jan. 11. Dr. Cool has a booth at the runDisney events, where consumers can try the product and talk to experts about the best recovery options. In addition, Dr. Cool and Coolcore combined efforts with ReY.S International to sponsor the Judo Grand Prix in Qingdao, China that took place Nov. 1. Athletes and coaches traveled from around the world to compete in the Qingdao Coolcore Cup.
Also as part of the product launch, Dr. Cool will partner with the Foundation for Physical Therapy to provide doctoral scholarships, fellowships and research grants to emerging physical therapist researchers.
Aisle7 launches interactive solution that helps educate patients on nutrient-drug interactions
PORTLAND, Ore. — Aisle7 on Thursday announced the launch of Healthnotes Interactions Checker, a next-generation solution simplifying the task of deciding which nutrients positively or negatively interact with the medicines they take. More than half of all Americans take some form of dietary supplement, and an estimated 40% of U.S. adults take both drugs and nutrients as part of their health regimen. Of these, 60% aren’t discussing possible interactions with their physician or pharmacist, Aisle7 noted.
“Over the last several months, we’ve spoken with pharmacists, doctors and our retail partners who tell us they see both a customer service and an information gap in the current prescription information delivery systems,” stated Skye Lininger, CEO of Aisle7. “The Healthnotes Interactions Checker solves this problem by seamlessly integrating with our clients’ environments—whether pharmacy-management systems, e-commerce sites, mobile platforms or health professional tools.”
“Today’s healthcare professionals are looking for the tools and resources they need to spend less time managing their business and more time caring for patients,” added Mandy Kraynik, VP Integrative Therapeutics. “Partnering with Aisle7 to introduce an interactive drug-nutrient interaction checker allows us to provide value to our customers in meaningful ways outside of nutritional supplements. Making new, dynamic tools like this available to healthcare professionals exemplifies our commitment to the integrative medicine community.”
The Healthnotes Interactions Checker has a simple interface: a person enters their current drugs and supplements into the list and the resulting report is easy-to-read and color-coded to clearly identify nutrients that have adverse or beneficial interactions with their medications. Reports can be printed or emailed to read later and share with a health professional.
Reports can also be automatically triggered as part of a prescription refill. The Healthnotes Interactions Checker accepts National Drug Codes from external pharmacy systems to create customized reports. When a refill is requested, a report can be auto-generated and delivered directly to the patient’s mobile phone. Or it can be made available at prescription pickup to discuss with their pharmacist, who can then highlight the nutrients to avoid due to safety concerns and which to add to support a medicine’s effectiveness or reduce side effects.