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...
Generic Name: HYDROCODONE/ACETAMINOPHEN - ORAL Pronounced: (HYE-droe-KOE-done/a-SEET-a-MIN-oh-fen) Hydrocodone-Acetaminophen Oral Interactions
See also Warning section.
The effects of some drugs can change if you take other
drugs or herbal products at the same time. This can increase your risk for
serious side effects or may cause your medications not to work correctly. These
drug interactions are possible, but do not always occur. Your doctor or
pharmacist can often prevent or manage interactions by changing how you use
your medications or by close monitoring.
To help your doctor or pharmacist give you the best care,
be sure to tell your doctor or pharmacist about all the products you use
(including prescription drugs, nonprescription drugs, and herbal products)
before starting treatment with this product. While using this product, do not
start, stop, or change the dosage of any other medicines you are using without
your doctor's a...
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