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

June 3, 2011

Formulary
Home Medication Safety FDA Actions Latest News Policy Watch Drug Watch
In This Issue
REMS now available for Avandia; access to drug restricted
Trilipix to stay on market, but FDA panel recommends new study
Antihyperglycemic agents useful as third agent, but class preference unclear
FDA approves Dificid for treatment of Clostridium difficile-associated diarrhea
Abiraterone acetate may improve survival for patients with metastatic advanced prostate cancer
Fixed-dose combination ARB plus CLD significantly lowers blood pressure
FDA approves Solesta for fecal incontinence in adult patients
Pfizer kidney cancer drug effective in phase 3 study
Study finds unexpectedly high risk of hypertension for young adults

Survey

This month we would like to know...

With several proton pump inhibitors now available OTC, what do you believe is the most appropriate coverage for this class of agents within managed care drug benefit programs?

1) No coverage should be provided for OTC or prescription products under the drug benefit.

2) Coverage of prescription products only under the drug benefit without restriction.

3) Coverage of prescription products only under the drug benefits with restrictions (eg, step therapy).

4) Coverage of both prescription and OTC products under the drug benefit without restriction.

5) Coverage of both prescription and OTC products under the drug benefit with restriction (eg, step therapy).

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Digital Edition

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REMS now available for Avandia; access to drug restricted

FDA announced May 18 to the public new restrictions to the prescribing, dispensing, and use of rosiglitazone-containing medications (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline) as part of a Risk Evaluation and Mitigation Strategy. The new restrictions require healthcare providers, including pharmacists, and patients to enroll in a special program in order to prescribe, dispense, and receive these drugs. Read full article.

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Trilipix to stay on market, but FDA panel recommends new study

An FDA advisory panel recommended fenofibric acid (Trilipix, Abbott) still be marketed for use but voted unanimously that Abbott be required to conduct a new study to determine whether a Trilipix-statin combination reduces heart attacks. Read full article.

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Antihyperglycemic agents useful as third agent, but class preference unclear

There is no clear difference in benefit between drug classes when adding an antihyperglycemic as a third agent to the treatment of patients with type 2 diabetes who are already receiving metformin and a sulfonylurea, according to a meta-analysis published in the May 17 issue of Annals of Internal Medicine. Read full article.

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FDA approves Dificid for treatment
of Clostridium difficile-associated diarrhea

FDA approved fidaxomicin (Dificid, Optimer Pharmaceuticals) tablets for the treatment of Clostridium difficile-associated diarrhea. Read full article.

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Abiraterone acetate may improve survival for patients with metastatic advanced prostate cancer

Patients with metastatic castration-resistant prostate cancer treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo, according to a phase 3 study published in the May 26 issue of the New England Journal of Medicine. Read full article.

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Fixed-dose combination ARB plus CLD significantly lowers blood pressure

An investigational fixed-dose therapy showed promising results in lowering blood pressure compared with study comparators, according to the results of three phase 3 studies presented at the 26th annual American Society of Hypertension Scientific Meeting and Exposition in New York. Read full article.

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FDA approves Solesta for fecal incontinence in adult patients

FDA has approved a sterile, injectable gel (Solesta, Oceana Therapeutics) as a treatment for fecal (bowel) incontinence in adult patients who have not responded to conservative therapy such as dietary control. Read full article.

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Pfizer kidney cancer drug effective
in phase III study

NEW YORK (Reuters) - A drug from Pfizer Inc delayed progression of advanced kidney cancer by nearly 7 months, and by 2 months longer than a commonly used medicine, in previously treated patients, according to data from a late-stage clinical trial. Read full article.

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Study finds unexpectedly high risk
of hypertension for young adults

Nearly 20% of young adults in the United States may have high blood pressure, according to an analysis of the NIH-funded National Longitudinal Study of Adolescent Health published online May 23 in Epidemiology. Read full article.

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Top 5 Web Stories

  1. FDA Pipeline Preview, May 2011 (Eli Lilly, Vertex, Regeneron Pharmaceuticals, Nile Therapeutics, Provectus)

  2. FDA Actions in Brief May 2011 (Actemra, Menactra, Zytiga, Rituxan, Invega, Vandetanib, Viramune XR, Horizant)

  3. A review of systemic lupus erythematosus and current treatment options

  4. Bazedoxifene: An investigational selective estrogen receptor modulator for the treatment and prevention of osteoporosis in postmenopausal women

  5. FDA, NIH, pharma companies seek new strategies to spur drug development
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