Earlier this month, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee overwhelmingly voted against recommending approval of Zohydro ER, an extended-release version of hydrocodone. If approved, Zohydro ER would have been the first hydrocodone medication available that did not also contain a non-opioid analgesic such as acetaminophen or ibuprofen.
While the FDA does not have to follow the recommendation of its advisory committee, it usually does. The final determination is expected to be made by March 1, 2013.
Despite the fact that Zohydro ER was studied in nearly 1,500 patients––some for as long as a year––and found to be generally safe and well-tolerated with no new or unexpected safety problems, panel members expressed concerns with potential abuse, addiction and long-term safety.
It was noted that the manufacturer didn't offer any solution as to how they would limit unintended use other than the already tight distributio...
On Monday, the pharmaceutical company Zogenix, Inc. announced the FDA had accepted for review their New Drug Application (NDA) for Zohydro ER™ (hydrocodone bitartrate extended-release capsules).
Hydrocodone is one of the most frequently prescribed opioid drugs for the management of moderate to severe chronic pain. There are, however, two features that set Zohydro ER apart from other hydrocodone products currently available:
It does not contain acetaminophen.
It is an extended-release medication.
Other hydrocodone medications currently available (like Vicodin and Lortab) all contain acetaminophen , which can be hard on the liver. They are also all immediate-release, meaning they have to be taken every four to six hours. Zohydro is intended to be administered every 12 hours to provide round-the-clock pain management for an extended period of time.
Under the Prescription Drug User Fee Act, the goal for a standard review of an NDA is 10 months from NDA subm...
There’s so much to love about the spring season. The warmer weather, brighter mornings and evenings, and longer days. They all seem to make life so much better. But for more than 50 million Americans, spring can be a double-edged sword. Spring marks the beginning of pollen season, and depending on where you live and local weather patterns, trees can signal the start of a dismal wave of allergy symptoms. So how can you avoid it?
Know When to Expect Your Triggers
Besides being beautiful to look at, trees are vital to human existence. They produce oxygen, clean the air and soil, help to prevent flooding, reduce noise, provide shade, and can even increase property values.
The downside is that some of them spew out millions of pollen grains that can travel hundreds of miles, and assault the allergic eyes and noses of millions of people. In the northern part of the U.S., certain trees pollinate early in the spring, such as Elm, Birch and Box Elder. Other types, suc...
You should knowAnswers to your question are meant to provide general health information but should not replace medical advice you receive from a doctor. No answers should be viewed as a diagnosis or recommended treatment for a condition. Content posted by community members does not necessarily reflect the views of Remedy Health Media, which also reserves the right to remove material deemed inappropriate.