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Ãֽž๰Á¤º¸ (FDA ½ÂÀÎ ¾à¹° 2014.3-2014.6)
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Epanova (omega-3-carboxylic acids); AstraZeneca; For the treatment of severe hypertriglyceridemia, Approved May 2014
Afrezza (insulin human) Inhalation Powder; Mannkind; For the treatment of diabetes mellitus, Approved June 2014Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of hypogonadism, Approved March 2014
Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of hypogonadism, Approved March 2014
Vogelxo (testosterone) gel; Upsher-Smith; For males with a deficiency or absence of endogenous testosterone, Approved June 2014
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014
Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid dependence, Approved June 2014
Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014
Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014
Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014
Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April 2014
Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014
Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn's disease, Approved May of 2014
Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014
Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] ; Biogen IDEC.; For the treatment of hemophillia A, Approved June 2014
Sylvant (siltuximab); Janssen Biotech; For the treatment of multicentric Castleman¡¯s disease, Approved April 2014
Zontivity (vorapaxar); Merck; For the reduction of thrombotic cardiovascular events, Approved May 2014
Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn's disease, Approved May of 2014
Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014
Incruse Ellipta (umeclidinium inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2014
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014
Impavido (miltefosine); Knight Therapeutics; For the treatment of visceral, cutaneous and mucosal leishmaniasis, Approved March 2014
Jublia (efinaconazole) 10% topical gel; Valeant Pharmaceuticals; For the treatment of onychomycosis of the toenails, Approved June 2014
Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals; For the treatment of acute bacterial skin and skin structure infections, Approved June 2014
Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014
Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014
Omidria (phenylephrine and ketorolac injection); Omeros; For use during eye surgery to prevent intraoperative miosis and reduce post-operative pain, Approved June 2014
Afrezza (insulin human) Inhalation Powder; Mannkind; For the treatment of diabetes mellitus, Approved June 2014Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of hypogonadism, Approved March 2014
Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of hypogonadism, Approved March 2014
Vogelxo (testosterone) gel; Upsher-Smith; For males with a deficiency or absence of endogenous testosterone, Approved June 2014
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014
Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid dependence, Approved June 2014
Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014
Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014
Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014
Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April 2014
Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014
Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn's disease, Approved May of 2014
Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014
Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] ; Biogen IDEC.; For the treatment of hemophillia A, Approved June 2014
Sylvant (siltuximab); Janssen Biotech; For the treatment of multicentric Castleman¡¯s disease, Approved April 2014
Zontivity (vorapaxar); Merck; For the reduction of thrombotic cardiovascular events, Approved May 2014
Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn's disease, Approved May of 2014
Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014
Incruse Ellipta (umeclidinium inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2014
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014
Impavido (miltefosine); Knight Therapeutics; For the treatment of visceral, cutaneous and mucosal leishmaniasis, Approved March 2014
Jublia (efinaconazole) 10% topical gel; Valeant Pharmaceuticals; For the treatment of onychomycosis of the toenails, Approved June 2014
Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals; For the treatment of acute bacterial skin and skin structure infections, Approved June 2014
Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014
Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014
Omidria (phenylephrine and ketorolac injection); Omeros; For use during eye surgery to prevent intraoperative miosis and reduce post-operative pain, Approved June 2014
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Ãֽž๰Á¤º¸ (FDA ½ÂÀÎ ¾à¹° 2014.7-2014.9) 2014-11-15 11:32
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Ãֽž๰Á¤º¸ (FDA ½ÂÀÎ ¾à¹° 2014.3-2014.6)
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·¹´Ñ-¾ÈÁö¿ÀÅٽŰè(RAS) ÀÛ¿ë ÀǾàǰ °ü·Ã ¾ÈÀü¼º ¼ÇÑ 2014-07-03 13:32
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