The FDA has declined to approve the Afrezza inhaled insulin device pending further data, device maker MannKind announced. The whistle-sized inhaler was designed to administer mealtime doses of powdered insulin in metered, single-use cartridges but ran into problems with the FDA over a redesign. More studies requested.
FDA limits amount of acetaminophen in prescription drugs. The FDA is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity. The FDA asked manufacturers of prescription drugs that contain the drug to limit it to 325 mg per tablet. Overdoses from prescription painkillers combining acetaminophen with another ingredient account for nearly half of all cases of acetaminophen-related liver failure often resulting in liver transplant or death. The risk usually is increased when patients take multiple drugs containing acetaminophen at once and exceed the current maximum dose of 4,000 mg within a 24-hour period.