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. 2014 Nov 14;49(10):975–984. doi: 10.1310/hjp4910-975

Table 1. New drugs approved by the US Food and Drug Administration (FDA): August 16, 2014 through September 15, 2014.

EliglustatCerdelga (Genzyme)
Comparative agents: Imiglucerase, Velaglucerase, Taliglucerase
Indication: Long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test
Mechanism of action: Specific inhibitor of glucosylceramide synthase
Common adverse effects: Fatigue, headache, nausea, diarrhea, back pain, pain in extremities, upper abdominal pain
Dosage form & strength: Capsules; 84 mg
Product labeling: http://www.cerdelga.com/pdf/cerdelga_prescribing_information.pdf

Ferric citrate – (Keryx Biopharmaceuticals)
Comparative agents: Calcium acetate, calcium carbonate, lanthanum carbonate, sevelamer hydrochloride, sevelamer carbonate, sucroferric oxyhydroxide
Indication: Control of serum phosphorus levels in patients with chronic kidney disease on dialysis
Mechanism of action: Iron-based phosphate binder complex
Common adverse effects: Diarrhea, discolored feces, constipation, nausea, and vomiting
Dosage form & strength: Oral; 210 mg ferric iron (equivalent to 1 g ferric citrate)
Product labeling: http://keryx.com/wp-content/uploads/Keryx_FerricCitrate_PI.pdf

Fluticasone furoate – Arnuity Ellipta (GlaxoSmithKline)
Comparative agents: Fluticasone propionate
Indication: Maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older
Mechanism of action: Corticosteroid; anti-inflammatory activity
Common adverse effects: Upper respiratory tract infection, nasopharyngitis, headache, and bronchitis
Dosage form & strength: Inhalation powder; 100 mcg, 200 mcg
Product labeling: https://www.gsksource.com/gskprm/htdocs/documents/ARNUITY-ELLIPTA-PI-PIL.PDF

Naltrexone HCl & Bupropion HCl – Contrave (Orexigen Therapeutics)
Comparative agents: Individual ingredients
Indication: Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)
Mechanism of action: Opioid antagonist; aminoketone antidepressant; mechanism for weight control unknown, but may be related to activity in the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system)
Common adverse effects: Nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea
Dosage form & strength: Extended-release tablet; naltrexone 8 mg/bupropion HCl 90 mg
Product labeling: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200063s000lbl.pdf

Peginterferon beta-1A – Plegridy (Biogen IDEC)
Comparative agents: Interferon beta 1-A
Indication: Treatment of patients with relapsing forms of multiple sclerosis
Mechanism of action: Unknown
Common adverse effects: Injection site erythremia, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia
Dosage form & strength: Injection – single-dose prefilled syringe; 63 mcg/0.5 mL, 94 mcg/0.5 mL, 125 mcg/0.5 mL
Product labeling: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499s000lbl.pdf