The approval marks a major step towards providing those who suffer from frequent heartburn broader access to a brand doctors and patients have trusted for years.
Pfizer acquired exclusive global rights to market non-prescription Nexium in 2012 from AstraZeneca.
The addition of the OTC drug to the Pfizer Consumer Healthcare portfolio expands the breadth of categories in which the company helps consumers better manage their health, and extends the value of the world’s leading prescription acid blocker brand.
Pfizer Consumer Healthcare president Paul Sturman said switching medicines, whenever appropriate, from prescription to non-prescription status improves access, empowers consumers to care for their own health and is an important strategy for Pfizer.
"The FDA approval of Nexium 24HR is a significant milestone in executing against our plan," Sturman said.
The company said that it will continue to work closely with AstraZeneca and retail partners to make Nexium 24HR available to consumers in the US, with other markets in Europe expected to follow later in 2014.