Rx-to-OTC USA

Switch Sponsors Weigh Business Opportunities Against Regulatory Risk

In 2020, the U.S. market saw four new brands previously sold as prescription drugs enter the nonprescription market: 

  • Pataday allergy eye drops 
  • Voltaren Arthritis Pain topical NSAID 
  • Advil Dual Action ibuprofen and acetaminophen pain reliever 
  • Sklice lice treatment 

The new switch approvals have signaled a willingness on the part of regulators to be less conservative when it comes to OTC access to these medicines.  Nasal steroid switches, like Flonase and Rhinocort, along with the topical NSAID Voltaren Arthritis Pain and Sklice lice shampoo, are all in categories where switch activity was curtailed in the not-so-distant past due to concerns over systemic absorption of topically applied medicines. For in-depth profiles of recently approved FDA switches, subscribe to the all-new KlinePULSE Consumer Healthcare Industry Trends service. Continue reading

Germicidal Product Categories I&I Cleaning

Industrial and Institutional Cleaning at the Forefront of Fighting Coronavirus

The commercial cleaning industry’s essential workers have been at the forefront of the fight against COVID-19 by keeping facilities clean and providing improved hand hygiene for building users. And those jobs have become more extensive  during the summer of 2020, Kline surveyed over 500 I&I end users and found that: 

  • 75% have increased the number of locations where hand sanitizer is available at their facilities 
  • 57% have increasethe frequency of cleaning  
  • 43% have increased the use of antibacterial hand soaps 
  • 43% have converted hand soap dispensers from manual to touch-free 

When asked how long they expect these changes to remain in place, 33% indicate into 2021, 22% have no expected time frame for changing back, and 18% said until there is a vaccine or treatment for coronavirus. Continue reading

ISSA Cleaning Show Highlights

ISSA Cleaning Show Highlights Industry Shift to Cleaning for Health

Sessions at this year’s ISSA cleaning trade show had a common theme: the importance of cleaning for health rather than cleaning for appearance.   

Before the coronavirus pandemic changed the world, the act of cleaning was usually done behind the scenes or after hours and often focused on cleaning for appearance by emptying waste bins, making sure surfaces and floors were free from debris, and ensuring restroom mirrors and counters were clean and shiny.  However, in 2020cleaning to kill germs and maintain the health and safety of building users has been the focus, with surface disinfection and hand hygiene being paramount. The cleaning task is now being carried out with much more frequency, and as building users see cleaning and disinfecting happening, they are assured of a commitment to cleaning for health.  In fact, cleaning professionals are very much front-line workers, helping to combat the spread of coronavirus, and are to be commended for doing more work, often with fewer resources.   Continue reading

Recent Rx-to-OTC Switches in the U.S.

Five Newly Approved Switches Hit the U.S. Market

The U.S. FDA approved five new branded Rx-to-OTC switches in 2020, including eye drops, an external analgesic, and a lice treatment. In additionprivate-label companies such as Perrigo and Mylan gained approval for store brand versions of Voltaren Arthritis Pain Gel, Prevacid 24HR proton pump inhibitor, and Nicorette smoking cessation gum this year. These approvals come after a lull in switch activity during the past two years.  Continue reading

Will Japan and Europe Switch Activity Impact the U.S. Market?

Embracing Rx-to-OTC Switch: Japan and Europe foster access to nonprescription medications, but will that have an impact on the United States market?

Recently, in Europe and Japan there have been increased Rx-to-OTC switch approvals and an environment fostering switch. The OTC men’s health category is growing in Europe, with the switch approval of Recordati’s Fortacin (lidocaine 7.5mg/prilocaine 2.5 mg) spray for premature ejaculation, via the centralized switch procedure through the European Medicines Agency. This drug marks the fifth medicine approved for switch through this centralized regulatory body, and it is expected to be launched throughout the EU on a nonprescription basis by early 2021. 

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Cleaning Needs in the Foodservice Industry are Rapidly Changing

The restaurant industry has been one of the hardest hit by the coronavirus pandemic, with government shutdowns leading to an estimated 8 million unemployed restaurant workers and thousands of temporary and permanent restaurant closures. Yelp estimates that approximately 16,000 restaurants have permanently closed due to COVID-19 lockdowns, and some project that the industry lost as much as $80 billion in the first two months of shelter-in-place orders. Continue reading

Foodservice Cleaning Products

Post-Lockdown: Hygiene and Food Safety Compliance is More Crucial Than Ever

As some coronavirus lockdowns are being lifted across the United States, restaurants are gradually reopening.  Some are operating indoors with limited capacity, others offer outdoor dining, and some are selling food for delivery and take out.  One thing they all have in common is that cleaning frequency has increased dramatically, and hygiene standards are more important than ever.     Continue reading

Personalization Trend Enters the Vitamin Market

Personalization Trend Enters the Vitamin Market

American consumers are increasingly using personalized subscription services for clothing, beauty productsand meal kits—plus vitamins and nutritional supplements. In a category worth more than $10 billion—with as much as 75% of the population regularly consuming supplements—the sheer number of available products and brands can be confusing. That’s why personalization makes sense, as it helps consumers navigate a somewhat perplexing category.   Continue reading

Staples hand care and janitorial cleaning

Staples Sets its Sights on Larger Janitorial Cleaning Accounts

About a decade ago, Staples started carrying select cleaning products in its stores to help offset declining sales and low margins on some office supplies being sold.  These products were largely targeted at small- to mid-sized commercial end users in office and professional settings, such as office managers. Therefore, the product mix was mainly surface wipes and restroom cleaning products.   Continue reading