Wednesday, 17 July 2019

USFDA approves Perrigo’s OTC heartburn medicine

11 April 2018 | News

Nexium 24HR (esomeprazole magnesium) capsules are indicated to treat frequent heartburn (occurs 2 or more days a week).

Singapore - Perrigo Company plc announced that it has received final approval from the U.S. Food & Drug Administration for the store brand OTC equivalent of Nexium 24HR (esomeprazole magnesium) capsules. The company also announced that it has reached a settlement of patent litigation with AstraZeneca allowing for the store brand OTC equivalent of Nexium 24HR (esomeprazole magnesium) capsules to launch in late September 2017. This product will be packaged and marketed as store brand or retailer 'own label' brand and will provide consumers with a high-quality, value alternative to Nexium 24HR capsules.

Nexium 24HR (esomeprazole magnesium) capsules are indicated to treat frequent heartburn (occurs 2 or more days a week).  Approximate annual retail sales for the last 12 months were in excess of $300 million.  

Perrigo Executive Vice President and President, Consumer Healthcare Americas Jeff Needham stated, "This final approval and upcoming launch demonstrates the tremendous capabilities of our leading store brand OTC platform. We are eager to finalize launch plans with our retail and wholesale partners to bring this major new product to consumers. Important product launches like the store brand equivalent of Nexium 24HR capsules are what drive the Perrigo advantage by providing our customers, consumers and families with high quality, value alternatives in important treatment categories."

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