Research & Development
Perrigo's Omeprazole Magnesium Delayed-Release Mini Capsules receives US FDA final approval
27 May 2022 -

Ireland-based pharmaceutical company Perrigo Company plc (NYSE: PRGO) announced on Thursday that the United States Food and Drug Administration (FDA) has granted final approval to the company for its Omeprazole Magnesium Delayed-Release Mini Capsules, 20mg over-the-counter (OTC).

The company is likely to launch Omeprazole Minis later this year. The product is a first-to-market mini capsule form of omeprazole that is indicated to treat frequent heartburn. The capsule is 70% smaller than the tablet version of omeprazole, which is presently available, providing a differentiated and preferred product offering for consumers. It will be marketed under retailer's store brand labels comparable to Prilosec OTC.

Perrigo executive vice president & president, Consumer Self-Care Americas, Jim Dillard said, '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. The omeprazole mini product exemplifies our national-brand-different strategy and provides our store brand partners with a differentiated product in the marketplace.'

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