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Weekly Drug News Round Up - October 30, 2013

Zohydro ER Approved as the First Single-Entity Hydrocodone Product

Zohydro ER is not approved for as-needed pain relief Read More...

The U.S. Food and Drug Administration (FDA) has approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. Zohydro ER, a Schedule II controlled substance, is the first FDA-approved single-entity and extended-release hydrocodone product. Zohydro ER labeling conforms to the updated labeling requirements for all long-acting opioid analgesics announced by the FDA in September. The most common side effects of Zohydro ER are constipation, nausea, drowsiness, fatigue, headache, dizziness, dry mouth, vomiting and itching.

DEA Schedule Change Likely for Combination Hydrocodone Products

The new regulations could take effect as early as 2014; final determination would be made by the Drug Enforcement Agency Read More

Hydrocodone combined with other analgesics - for example, acetaminophen - may soon undergo major changes in patient access. The U.S. Food and Drug Administration (FDA) has recommended that combination hydrocodone products (for example, Vicodin, Lortab) be changed from Class III under the Controlled Substance Act to Class II. This change means that the physician cannot call in the prescription or refills over the phone, and the written prescription must be physically presented to the pharmacist by the patient or caregiver. Additionally, more stringent requirements for storage and record keeping will be required in the pharmacy. As Schedule II drugs, these products will be subject to the same type of strict control as other medications with the highest potential for abuse, including OxyContin, Adderall and Ritalin.

Vizamyl Approved to Detect Beta Amyloid in Dementia

Dementia is associated with diminishing brain functions such as memory, judgment, language and complex motor skills Read More...

By 2025, close to 7 million people over the age of 65 years are predicted to have Alzheimer’s disease (AD) -- a 40 percent increase from the 5 million seniors currently affected. The U.S. Food and Drug Administration (FDA) has approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for AD and dementia. Vizamyl is the second diagnostic drug approved for this use; in 2012, FDA approved Amyvid (florbetapir F 18 injection) to help evaluate adults for AD and other causes of cognitive decline.

FDA Advisory Committee Backs Gilead’s Sofosbuvir for Hepatitis C

According to analysts, sofosbuvir annual sales could reach $4 billion by 2016 Read More...

A U.S. Food and Drug Administration (FDA) Advisory panel has voted unanimously to recommend approval of sofosbuvir, Gilead’s once daily, oral nucleotide analog inhibitor for the treatment of chronic hepatitis C virus (HCV) in adults. Interest lies in using Gilead's sofosbuvir in interferon-free, all-oral regimens for HCV treatment. Data support using sofosbuvir in combination with ribavirin for the treatment of HCV (genotype 2 and 3 infection) and for use with pegylated interferon and ribavirin for the treatment of HCV in treatment-naïve adults (genotype 1 and 4 infection). The FDA is expected to make its final decision by December 8, 2013.

DEA Questions Whether Krokodil Has Actually Reached the U.S.

Krokodil is popular in Russia because heroin is scarce and expensive, and krokodil is a cheaper, home-cooked substitute Read More…

Recent media reports suggest that a new, horrific drug of abuse - Krokodil - is making its way around the United States. Drug Enforcement Agency (DEA) officials say they are not sure if the reports are actually krokodil - some have turned out to be heroin - and they continue to test drug samples from cities where reports originate. Krokodil gets its street name from its devastating effects - after injection it turns human skin green and scaly, like a crocodile; skin eventually turns gangrenous and dies. This effect is no surprise - Krokodil is made by combining codeine pills with caustic ingredients such as gasoline, red phosphorus from match tips, alcohol, and iodine.

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