Pfizer Statement on U.S. FDA Approval of Over-the-Counter Nexium 24HR
Friday, March 28, 2014 - Today the U.S. Food and Drug Administration (FDA) approved over-the-counter Nexium 24HR (esomeprazole 20mg) marking a key step towards providing those who suffer from frequent heartburn broader access to a brand doctors and patients have trusted for years.
In 2012, Pfizer acquired exclusive global rights from AstraZeneca to market non-prescription Nexium. The addition of Nexium 24HR to the Pfizer Consumer Healthcare portfolio expands the breadth of categories in which we help consumers better manage their health, and extends the value of the world’s leading prescription acid blocker brand.
“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,” said Paul Sturman, President, Pfizer Consumer Healthcare. “The FDA approval of Nexium 24HR is a significant milestone in executing against our plan.”
We continue to work closely with AstraZeneca and retail partners to make Nexium 24HR available to consumers in the U.S., with other markets in Europe expected to follow this year.
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Posted: March 2014
- FDA Approves Nexium I.V. (Esomeprazole Sodium) for the Treatment of Gastroesophageal Reflux Disease (GERD) With Erosive Esophagitis in Pediatric and Adolescent Patients - May 2, 2011
- FDA Approves Nexium for Use in Children Ages 1-11 Years - February 28, 2008
- FDA Approves Nexium for the Treatment of Zollinger-Ellison Syndrome - October 12, 2006
- Nexium Approved for Children 12 to 17 For Short-Term Treatment of GERD - May 1, 2006
- Nexium IV Approved for Gastroesophageal Reflux Disease (GERD) - March 31, 2005
- Nexium approved for reduced risk of stomach ulcer development among NSAID users - November 29, 2004
- FDA Approves Nexium for Erosive Esophagitis, Gastroesophageal Reflux Disease and Prevention of Duodenal Ulcers - February 20, 2001