Ranitidine under regulatory spotlight

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Two weeks ago, the FDA put out a statement saying it had learned that some ranitidine medicines were found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels, which it classifies as a probable human carcinogen. In response, the FDA is conducting an ongoing investigation, working with international regulators and industry partners to determine the source of this impurity. Though the FDA made clear it is not calling for individuals to stop taking ranitidine, its advice to people taking OTC ranitidine was to consider using other OTC medicines approved for their condition.

Last week, the FDA alerted healthcare professionals and patients to a voluntary recall of OTC ranitidine tablets (75mg and 150mg) labelled by Walgreens, Walmart and Rite-Aid, and manufactured by Apotex. Sandoz (Novartis) also said it would no longer be distributing generic versions of ranitidine. This was followed by an announcement over the weekend that US retailer CVS is pulling the No.1 ranitidine-based OTC brand, Zantac (Sanofi), from its shelves over the possible links to cancer. CVS’ own generic ranitidine-based OTC products will also not be carried in the stores moving forward.

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Heartburn remedy Zantac is comfortably the No.1 ranitidine-based OTC brand, with global sales of around US$160mn (the vast majority of which are generated in North America). Chattem (Sanofi) markets Zantac in the USA in 75mg and 150mg OTC versions, while Aspen markets the brand in Australia and Perrigo is the UK marketer. In August 2018, Chattem extended its Zantac 150 line-up with two larger, value size 90-count SKUs, boosting sales significantly.

In a statement published in USA Today, Sanofi spokeswoman Ashleigh Koss said the company has no plans to halt shipments in the US market, adding: “The FDA reported that the levels of NDMA in ranitidine in preliminary tests barely exceed amounts found in common foods. We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards.”

Take an in-depth exploration of the Lower GIs market in Nicholas Hall’s Lower GIs: Trends & Opportunities in Laxatives, Antidiarrhoeals, Probiotics, Antispasmodics & IBS remedies report. This key title includes dedicated case studies, NPD, innovative line extensions, coverage of 10 major markets, sales data and forecasts, plus much more! To find out more or to order your copy today, please contact melissa.lee@NicholasHall.com.

OTCs In Action: Innovative Ayurvedic Acid Relief On the Go

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OTCs are in Action in India, where Sun Pharma’s new Pepmelt updates traditional Ayurvedic medicine with fast-melt granules for speedy relief of acid indigestion and heartburn, allowing Indians to enjoy impromptu meals with friends or new acquaintances.

 “The pioneering innovation of a mouth-melt antacid arose from a big need gap our market research indicated,” said Subodh Marwah, VP & Business Head – Global Consumer Healthcare. “Consumers today lead a very hectic life, eat out a lot and are always on the move. Thus, an easy-to-carry and convenient to use mouth-melt antacid makes Pepmelt extremely relevant to our consumers’ needs. Moreover, the idea of enjoying food without any fear is a key distinction for Pepmelt’s positioning in the antacid category.”

Lowe Lintas’ digital campaign for Pepmelt welcomes heartburn sufferers to the table. “A category defining innovation like Pepmelt, which is also a category disruptive introduction, needs a distinct and refreshing insight,” observed Marwah.”The campaign idea stems from the insight of offering food to someone who’s suffering from heartburn and acidity. This insight is fused into India’s socio-cultural context to create a potentially powerful and progressive brand idea for Pepmelt.”

Big Growth for the New Year – Nicholas Hall’s OTC INSIGHT Latin America

Cath INSIGHT Header 2014We have just published the January / February issue of OTC INSIGHT Latin America. Our Market Report focuses on Gastrointestinals and it has been a good year for the industry with each Big 4 country and all sub-categories posting growth. Lots of activity has been seen in antacids & antiflatulents where a flurry of innovative launches and line extensions have increased competition. Marketers are expanding their consumer base by extending brands into niche segments, such as Bayer’s Alka-Seltzer Boost in Mexico, positioned to relieve hangovers, while on-the-go line extensions from GSK and Hypermarcas in Brazil offer consumers convenience.

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