FDA approves miniature capsule formulation of omeprazole magnesium for heartburn
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The FDA has given final approval to Perrigo Co.’s miniature 20 mg delayed-release omeprazole magnesium capsules for over-the-counter treatment of frequent heartburn., according to a company press release.
Approximately 70% smaller than the standard tablet version of omeprazole currently available, the “first-to-market” miniature capsule is intended to “provide a differentiated and preferred product offering for consumers,” noted the press release.
“This approval illustrates Perrigo’s research and development and regulatory expertise and our continued focus on product innovation to provide value for both our customers and consumers,” Jim E. Dillard III, Perrigo executive vice president and president of consumer self-care Americas, said in the release. “The omeprazole mini product exemplifies our national-brand-different strategy and provides our store brand partners with a differentiated product in the marketplace.”
Perrigo expects to launch this product later in 2022, marketing it under retailer’s store brand labels comparable to Prilosec OTC.
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