For pharmacists, from Drug Topics: News stories about FDA drug reform and latest approvals - Drug Topics

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For pharmacists, from Drug Topics: FDA news, updates, and alerts affecting pharmacists, pharmacies, and pharmacy technicians

FDA panel votes against wider use of denosumab for prostate-cancer patients

February 9, 2012

An FDA advisory panel recommended against using denosumab (Xgeva, Amgen) to delay or prevent the spread of castration-resistant prostate cancer at risk for bone metastases. The FDA?s Oncologic Drugs Advisory Committee concluded that the drug offered a statistical benefit but not a clinical benefit.

FDA extends approval for Vyvanse to treat adult ADHD

February 8, 2012

FDA has approved lisdexamfetamine dimesylate (Vyvanse, Shire) capsules, (CII) as a maintenance treatment for adults with ADHD. Vyvanse was already approved as a treatment for ADHD in patients aged 6 to 17 years.

FDA grants priority review to GI agent for controlling diarrhea in HIV/AIDS patients

February 7, 2012

FDA has granted priority review to crofelemer 125-mg tablets (Salix Pharmaceuticals) for the control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART).

FDA approves extended-release tablets for type 2 diabetes

February 3, 2012

FDA approved sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.

Ivacaftor approved by FDA to treat rare form of cystic fibrosis

February 2, 2012

FDA approved ivacaftor (Kalydeco, Vertex Pharmaceuticals) for the treatment of a rare form of cystic fibrosis in patients aged 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator gene.

Diabetes drug dapagliflozin fails to get approval from FDA

February 2, 2012

FDA declined approval of the diabetes drug dapagliflozin (Bristol-Myers Squibb and AstraZeneca), based on the recommendations of 1 of its advisory committees.

FDA approves tablets for the treatment of adults with type 2 diabetes

February 2, 2012

FDA has approved linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, a new tablet that provides a single-tablet treatment option, taken twice-daily, for adult patients who need to control their blood sugar.

FDA approves axitinib to treat renal cell carcinoma

January 31, 2012

FDA approved axitinib (Inlyta, Pfizer) to treat patients with an advanced kidney cancer called renal cell carcinoma who have not responded to another drug for this type of cancer.

Review raises questions about why government stockpiling zanamivir, oseltamivir

January 31, 2012

Zanamivir and oseltamivir (Tamiflu, Roche) can help prevent and treat the symptoms of influenza, but there is not enough information to evaluate the drugs’ safety and efficacy for preventing the spread of flu or pneumonia, according to a new review published online January 18.

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Drug Topics is a monthly news magazine, guided by a board of pharmacy leaders, reporting on all phases of community, retail, and health-system issues and trends. We cover managed care and professional, national, and state activities as well as new therapies involving prescription and OTC drugs.
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