Ibuprofen Sodium Dihydrate

DUBLIN, March 1, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg, the store brand over-the-counter ("OTC") equivalent of Advil® Dual Action Tablets 250 mg/125 mg. The Company anticipates launching the product by Spring 2023. Perrigo Executive Vice President & President, Consumer Self-Care Americas, Jim Dillard commented, "Following the successful approval and launch of Perrigo's first self-led branded prescription-to-OTC switch of Nasonex24HR®, this prescription-to-OTC approval further exemplifies the strength of our regulatory and development capabilities, enabling our business to quickly follow national brand innovation and consumer preferences. This approval was received on the first day possible following the expiration of the marketing exclusivity for Advil® Dual Action Tablets 250 mg/125 mg." Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg provides relief for multiple pain related symptoms by combining two ingredients indicated for OTC pain relief. Retail sales for the national brand equivalent product for the last twelve months ending January 29, 2023, were approximately $69 million based on IRI multi-outlet market data. Important safety information about Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg Before using the product, consumers should read the Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg drug facts label. About Perrigo Perrigo Company plc (NYSE: PRGO) is a leading provider of Consumer Self-Care Products and over-the-counter (OTC) health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at . Forward-Looking Statements This press release includes certain "forward-looking statements" within the meaning of the Private Litigation Securities Reform Act of 1995, as amended. Forward-looking statements relate to future events, such as future product sales and regulatory capabilities, and involve known and unknown risks, uncertainties and other factors—many of which beyond the Company's control—that may cause the actual results, performance or achievements of the Company to be materially different from its current expectations, assumptions, estimates and projections. Interested persons are urged to consult the Company's filings with the United States Securities and Exchange Commission, available at , for a discussion of the Company's business and financial condition and certain material trends, risks, uncertainties and other factors relating thereto, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2022. Company Codes: NYSE:PRGO

Tying shoes, walking downstairs, entering a car, or simply carrying your grandchild — there are innumerable everyday activities that blend into our background. Most of us barely think about them. But, for 127 million Americans with musculoskeletal (MSK) pain, those everyday background movements jump into the foreground. Unlike heart attacks, strokes, or cancer, MSK conditions won’t appear on any rankings for leading causes of death in America. That’s because the impact of MSK conditions typically sneaks up on us over time, as with arthritis which compounds gradually over many years. Moreover, MSK conditions can be several dominos upstream of other healthcare events. When the statistics record a heart attack, what goes unmentioned is comorbid arthritis that makes exercise too painful – present in more than half of patients with heart disease. Whether it’s weight gain or depression, or social isolation – it’s almost impossible to stay healthy when it’s too painful to move. While the mortality tables may be missing the upstream domino of MSK, the actuaries certainly are not. MSK conditions cost the U.S. economy a staggering $600 billion, with about half that cost avoidable. Moreover, MSK spend doubled over the last decade, fueled by elective surgeries, without noticeable improvement in outcomes. Behind the economic cost is the hidden human toll—the fear of constant pain, anxiety, and depression. Many patients see MSK as “just part of getting old,” taking Advil and Tylenol until it’s time for a hip replacement, but it doesn’t have to be that way. Physical therapy (PT) has long been shown to be as effective as back or knee surgery for common conditions. But a course of PT means sitting in traffic, copays, babysitters, and missed work. New technologies such as wearable sensors and AI-driven computer vision are now able to capture a patient’s movement right from home with the same fidelity as Hollywood motion picture labs – delivering therapeutic exercises using a smartphone or tablet. Ensuring equitable and personalized care Every person’s MSK condition is unique and influenced by biological, psychological, and social factors. This explains why different populations—people of color and residents in rural areas—are impacted differently or disproportionately. Analyses of the recent CDC National Health Interview Survey showed people of color and lower income groups with chronic pain and mental health conditions are more likely to experience higher pain levels and a greater impact on their daily lives. One in four women have dysfunction with their pelvic floor muscles that can cause ongoing pain, urinary urgency, or even leakage after a cough. On average, women suffer for 6.5 years before seeking care due to a lack of awareness and limited access to pelvic floor physical therapists. Older adults, long considered digitally naive, are embracing digital physical therapy care with higher adherence rates than younger people. Pain, lack of balance, and fearing a loss of independence are prime motivators to pick up technology. A recent study with a Medicare population shows older adults who participated in a digital PT program reported much lower MSK-related costs – 6.2x less than those who received only in-person physical therapy. Technology makes it possible to deliver both consistent and personalized care – whether you’re in rural Montana or downtown Manhattan. Treating the whole person Your musculoskeletal system is a hub for your overall health, impacting and being impacted by: lifestyle, behavioral, and emotional risk factors such as lack of sleep, depression, stress, or obesity. That’s why it’s difficult to address knee arthritis or chronic back pain in isolation. What’s required is a holistic approach to MSK care – delivering not just physical therapy but lifestyle modifications and mental health support. The most thoughtfully designed MSK care programs (digital or otherwise) involve multidisciplinary care teams combining physical therapists, doctors, nutritionists, health coaches, and even social workers. The growing adoption of digital care for back and joint pain Over four hundred thousand Americans will turn to a digital PT program this year, up 1000% from just a few years ago. This is an encouraging sign as more and more people who didn’t have access to PT can now take advantage of it. Continuing to find ways to access these new technologies will help us further bridge the care gap and give more people the chance to live healthier, happier lives.