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Formulary, A peer-reviewed drug management journal for managed care and hospital decision-makers
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FormularyJournal.com

April 29, 2011

Formulary
Home Medication Safety FDA Actions Latest News Policy Watch Drug Watch
In This Issue
White House, FDA act to reduce opioid misuse and abuse
Accu-Chek infusion set recalled
Dalteparin not better than unfractionated heparin for preventing DVT
New analysis shows fingolimod delays progression of MS disability
FDA launches consumer-friendly recall website
Twice-daily exenatide added to basal insulin improves glycemic control

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This month we would like to know...

Fingolimod (Gilenya) was recently FDA approved in the treatment of relapsing remitting multiple sclerosis (RRMS). How is your health system covering or planning on covering this new oral disease-modifying therapy (DMT)?

1) We will be/are covering it only for patients who have failed injectable DMTs (both in the interferon class and glatiramer acetate).

2) We will be/are covering it only for patients who have failed injectable DMTs (either an interferon or glatiramer acetate).

3) We will be/are covering it for patients that meet certain criteria. However, the main criteria does not have to be failure of an injectable DMT.

4) We will be/are covering it for patients with a new diagnosis of RRMS only.

5) We will not be covering it at all until more data is available.

6) We have not yet decided how to cover this product.

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White House, FDA act to reduce opioid misuse and abuse

The Obama administration recently unveiled a multiagency plan to reduce the "epidemic" of prescription drug abuse in the United States. It will include an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids. Read full article.

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Accu-Chek infusion set recalled

Roche recently recalled its Accu-Chek FlexLink Plus infusion sets globally because they may under-deliver insulin to patients. Read full article.

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Dalteparin not better than unfractionated heparin for preventing DVT

Dalteparin was not better than unfractionated heparin for the prevention of deep vein thrombosis among critically ill patients, according to an international study published in the New England Journal of Medicine. Read full article.

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New analysis shows fingolimod delays progression of MS disability

Fingolimod (Gilenya, Novartis) reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis, regardless of treatment history, according to a phase 3, 2-year study reported at the 63rd annual meeting of the American Academy of Neurology. Read full article.

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FDA launches consumer-friendly recall website

This month, FDA launched its revamped Recalls, Market Withdrawals, and Safety Alerts website, making it easier for consumers to search and view food and product recall information going back to 2009. Read full article.

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Twice-daily exenatide added to basal insulin improves glycemic control without excess hypoglycemia or weight gain

Adding twice-daily exenatide injections to (basal) insulin glargine improved glycemic control without increasing the risk for hypoglycemia or weight gain in patients with uncontrolled type 2 diabetes, according to a randomized and placebo-controlled trial. Read full article.

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Top 5 Web Stories

  1. Ceftaroline: A novel cephalosporin with methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae activity

  2. Treatment of bipolar disorder: A focus on medication therapy for mania

  3. Vilazodone hydrochloride (Viibryd): A selective serotonin reuptake inhibitor and partial 5HT1A receptor agonist for the treatment of major depressive disorder

  4. Fentanyl sublingual tablets (Abstral): An opioid analgesic for the management of breakthrough pain in cancer patients

  5. FDA Pipeline Preview, March 2011 (Contrave, rabeprazole sodium extended-release capsules, Avodart, Mu Delta, Carfilzomib, Vascugel, INX-0818, vosaroxin, Acurox, fidaxomicin, melanoma cancer vaccine, NSI-566RSC, Regorafenib)
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