NOVEL PHARMACEUTICALS 2014
Indication: To increase systemic exposure of atazanavir or darunavir (once-daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection Uceris (new formulation) (Budesonide; Salix Pharmaceuticals) Class/route: Glucocorticosteroid; rectal foam New formulation: Rectal foam; already available in extended-release tablet Indication: For the induction of remission in patients with active mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge Vazculep (new dosages/formulation) (Phenylephrine hydrochloride; Éclat Pharmaceuticals) Class/route: Alpha-1 adrenergic receptor agonist; intravenous New dosages/formulation: 5-mL and 10-mL pharmacy bulk package vials; already available as a 1-mL single-use vial Indication: For the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia Vogelxo (new formulation) (Testosterone; Upsher-Smith Laboratories) Class/route: Androgen; topical
New formulation: Gel formulation Indication: For testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, such as primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired) Xartemis XR (new formulation) (Oxycodone hydrochloride and acetaminophen; Mallinckrodt Brand Pharmaceuticals) Class/route: Opioid agonist; oral New formulation: Extended-release tablet Indication: For the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate Approval consideration: Priority review Zubsolv (new dosage) (Buprenorphine and naloxone; Orexo US) Class/route: Partial opioid agonist; sublingual New dosages: 8.6-mg/2.1-mg and 11.4-mg/2.9-mg buprenorphine/naloxone CIII sublingual tablets; already available as 5.7-mg/1.4-mg and 1.4-mg/0.36-mg tablets Indication: For the maintenance treatment of opioid dependence
CFTR indicates cystic fibrosis transmembrane conductance regulator; COPD, chronic obstructive pulmonary disease; GLP-1, glucagon-like peptide-1; NSAID, nonsteroidal anti-inflammatory drug; REMS, Risk Evaluation and Mitigation Strategy.
IV. New Vaccines and New Blood Products Approved in 2014 Alprolix (new blood product) (Coagulation factor IX [recombinant], Fc fusion protein; Biogen Idec) Route: Intravenous Indications: In adults and children with hemophilia B to control and prevent bleeding episodes, for perioperative management, and for routine prophylaxis to prevent or reduce the frequency of bleeding episodes Elocate (new blood product) (Antihemophilic factor [recombinant], Fc fusion protein; Biogen Idec) Route: Intravenous Indications: In adults and children with hemophilia A (congenital factor VIII deficiency) for the control and
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prevention of bleeding episodes, for perioperative management, and for routine prophylaxis to prevent or reduce the frequency of bleeding episodes Fluzone Quadrivalent (new vaccine) (Influenza vaccine; Sanofi Pasteur) Route: Intradermal Indication: For active immunization for the prevention of influenza disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine Gardasil 9 (new vaccine) (Human papillomavirus 9-valent vaccine, recombinant; Merck Sharp & Dohme Corporation) Route: Intramuscular
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March 2015
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Vol 8
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Special Feature