GSK and Alcon get FDA approval for US switches

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Following on from our recent blog highlighting the need for a new wave of Rx-to-OTC switches to kickstart growth in the global consumer healthcare industry, this week we cover the welcome news that the FDA has approved three drugs for non-prescription use. As well as GSK’s topical analgesic gel Voltaren Arthritis Pain (diclofenac sodium 1%), two Alcon eye care allergy products (available as solution / drops) have also switched to OTC status – Pataday Twice Daily Relief (olopatadine 0.1%) and Pataday Once Daily Relief (olopatadine 0.2%).

Karen Mahoney, Acting Deputy Director of the Office of Nonprescription Drugs at the FDA’s Center for Drug Evaluation & Research, said: “Approval of a wider range of non-prescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”

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Olopatadine is available OTC in a handful of other countries worldwide, but this is the first time it’s been switched in a major market. One of the countries where the ingredient can be purchased without a prescription is Singapore, which approved the Rx-to-OTC switch of olopatadine 0.1% and 0.2% in December 2016. More recently, Poland’s Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) approved the Rx-to-OTC switch of Polfa Warszawa’s Starelltec Alergia eye drops (olopatadine 1mg / ml; 5ml bottle) in July 2019 and Adamed’s Oftahist eye drops (olopatadine 1mg / ml; 5ml bottle) in November 2019.

Voltaren currently ranks fifth among the world’s leading consumer healthcare brands, according to CHC DASHBOARD, and this switch could see it move up the rankings and even move ahead of its new GSK stablemate Advil into the No.3 position globally within the next few years. While the US switch of Voltaren has long been mooted, the news is all the more welcome at a time when the world’s No.1 CHC market is in desperate need of an injection of growth, and US arthritis sufferers are also in need of a wider pool of OTC non-opioid treatment options.

For the full story, be sure to read tomorrow’s edition of CHC.NewDirections, a weekly e-newsletter sent out every Tuesday. CHC.NewDirections focuses on innovation, science and regulation, and coverage spans Rx-to-OTC switch, CBD, relevant medical research, probiotics, medical devices, digital health / AI, e-cigarettes and much more! For more information, or to arrange a free trial, please contact Melissa.Lee@NicholasHall.com

OTCs in Action Episode 41: Eyes on India

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Last week, OTC.Newsflash reported that Bal Pharma is dilating its portfolio with the launch of Eye Spa lubricating eye drops, zoning in on two OTC sweet spots: India and eye care. The Indian OTC market grew by 41% to $2.4bn from 2010 to 2014; Nicholas Hall’s DB6 Global OTC database projects growth of more than 50% over the next five years – and very optimistically, we could see a 10-year trend of 150% growth. The eye care category in India has just about doubled in the past five years to $41.4mn.

The growth of OTCs, especially lifestyle categories, are closely linked to higher income levels. For a Swedish bird’s eye view of the demographic trend that will drive this growth in India, visit statistician Hans Rosling’s Gapminder website for an entertaining historical perspective, and learn the date he predicts that income per person in India and China will match that of the US:

 

That said, in a 2009 interview in India’s Economic Times, Rosling qualifies his growth predictions:

“What I am most worried about is the reaction of the western world when they see India and China become bigger, what really worries me is a possible war. I also see new, subtle trade barriers emerge. For instance, they are calling products manufactured by India and China as contaminated, and are getting experts and researchers to prove that. These trade barriers are very subtle.”