FDA approves OTC Nexium

April 3, 2014

FDA has approved non-prescription esomeprazole 20mg (Nexium 24HR, Pfizer).

FDA has approved over-the-counter (OTC) esomeprazole 20mg (Nexium 24HR, Pfizer).

Pfizer acquired exclusive global rights from AstraZeneca in 2012 to market non-prescription Nexium, a popular medication for people suffering frequent heartburn.

“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.”

In 2013 global sales of Nexium reached $7.8 billion and was ranked number 6th in sales volume worldwide, according to IMS Health MIDAS (December 2013).

Sturman said the non-prescription Nexium will be available in the United States this year.