Covidien (NYSE: COV), a leading global provider of healthcare products and the world's largest producer of acetaminophen, supports the U.S. Food and Drug Administration (FDA) on the safe use of acetaminophen.
This morning, the FDA requested manufacturers to voluntarily limit the acetaminophen content of each prescription pill or capsule to no more than 325 mg within three years. In addition, the agency announced new labeling requirements for prescription products containing acetaminophen.
Covidien is the only North American manufacturer of acetaminophen. The Company also manufactures prescription products that combine acetaminophen with the pain medications hydrocodone and oxycodone, all of which are already available in 325 mg formulations.
Based on its current understanding of the FDA action, Covidien does not anticipate a material impact to its fiscal 2011 Pharmaceuticals sales, operating income or Company operating margin.