Sanofi’s push into the over-the-counter (OTC) pharmaceutical sector has received a boost with the US approval of its Nasacort Allergy 24HR nasal spray.
The approval by the Food and Drug Administration (FDA) expands Sanofi’s OTC portfolio, which has been a key strategic sector for the company since 2008 and led to its $1.9bn acquisition of Chattem in March 2010, giving it a presence in the US consumer healthcare market.
Nasacort Allergy 24HR (triamcinolone) is the second allergy product Sanofi has moved from prescription-only to OTC status, after its Allegra (fexofenadine) was switched in 2011. This has become one of Chattem’s most successful product launches with sales of €164m in the first six months of this year, making it the division’s biggest brand.
The new product has been approved for seasonal and year-round nasal allergies in adults and children 2 years of age and older, and is the first and only medicine in its class to be available without a prescription, said Sanofi.
Chattem said it will launch Nasacort Allergy 24HR next Spring – in time for the allergy season – and claims it is the only single-agent OTC medicine that relieves the full range of nasal allergy symptoms, including nasal congestion, for 24 hours with a single daily dose.
Sanofi’s acquisition of Chattem was followed by the takeover of the Rolaids range of OTC antacids from Johnson & Johnson’s McNeil Consumer Healthcare unit in January, re-launching the brand in the US last month.
The US accounts for around a quarter of the global OTC pharmaceutical market, according to Sanofi, which also sees significant growth opportunities for the division in China and emerging markets.
The company posted consumer healthcare sales of €1.5bn in the first six months of this year, up around 2.5 per cent compared to the same period of 2012, with emerging markets accounting for around 48 per cent of that total.