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Recent FDA action (through October 2012) related to, Treprostinil diethanolamine extended release tablets, Lomitapide, Mipomersen sodium, Xilonix, Ponatinib, Trospium chloride extended-release capsules

New combination: FDA approved the combination tablet of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (Truvada, Gilead Sciences) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV-1 in adults at high-risk in combination with safer sex practices.

Recent FDA Approvals (through October 2012) related to (Perampanel, Eisai, Ocriplasmin, ThromboGenics, Paclitaxel protein-bound particles for injectable suspension, Celgene, tocilizumab, Genentech, Cysteamine ophthalmic solution, Sigma-Tau Pharmaceuticals, APTIMA HPV 16 18/45 Genotype Assay, Hologic, Adalimumab, Abbott, Regorafenib, Bayer HealthCare, Onyx)

Vascepa (Icosapent ethyl)

New molecular entity: FDA approved icosapent ethyl (Vascepa, Amarin Pharmaceuticals Ireland Limited), an ethyl ester of eicosapentaenoic acid (EPA), as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia.

FDA has approved omacetaxine mepesuccinate (Synribo, Teva) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. An estimated 5,430 people will be diagnosed with CML in 2012, according to the National Institutes of Health. Synribo is intended to be used in patients whose cancer progressed after treatment with at least 2 drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML.

Long-term treatment of folic acid and vitamin B6 and vitamin12 had no statistically significant effect on colorectal adenoma among women who were at high risk for cardiovascular disease, according to recent study published in the Journal of the National Cancer Institute.

Half of the 3.2 billion prescriptions dispensed annually are not taken as prescribed. Pharmacy benefit leaders must reconsider the financial context of medication adherence and medication possession, according to industry leaders presenting at an online seminar for the Pharmacy Benefit Management Institute in October.

The Advisory Committee for Immunization Practices (ACIP) voted to recommend the use of Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (MenHibrix, GlaxoSmithKline) in infants at increased risk for bacterial meningitis.

Numerous health and safety violations related to the practice of pharmacy at the New England Compounding Center (NECC), Framingham, Mass. have been documented by investigators of the Massachusetts Department of Public Health (DPH), according to Madeleine Biondolillo, MD, in a press conference Oct. 23

Three investigational drugs will be studied in a worldwide clinical trial to determine whether they can prevent Alzheimer’s disease. In people with inherited mutations that cause early-onset Alzheimer’s, the study will seek to identify whether the drugs can improve Alzheimer’s disease biomarkers and prevent the loss of cognitive function.