sábado, 12 de octubre de 2013

Nuevos Medicamentos Aprobados por la FDA en 2013

La siguiente Base de Datos contiene los medicamentios arobados por la Administracion de Drogas y Alimentos (FDA) para su venta en los Estados Unidos. Los enlaces pueden llevarlo a la pagina de la FDA donde podra encontrar indicaciones y mayor informacion en ingles,

Cardiologia/Enfermedades Vasculares

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013.

Dermatologia

Mekinist (trametinib); GlaxoSmithKline; Para el tratamiento de melanoma metastasico con la mutacion BRAF V600E, Aprobado Mayo 2013
Mirvaso (brimonidine); Galderma Labs; Para el tratamiento de eritema facial de rosacea, Aprobado Agosto 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; Para el tratamiento de herpes labialis recurrente en adultos, Aprobado Abril 2013
Tafinlar (dabrafenib); GlaxoSmithKline; Para el tratamiento de melanoma metastasico con la mutacion BRAF V600E, Aprobado Mayo 2013
Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; Para el tratamiento de micosis fungoide cutanea fase IA/IB, Aprobado Agosto 2013.

Equipos 

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; Para el tratamiento de EBPOC, Aprobado Mayo 2013.


Endocrinologia

Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals; For the treatment of vasomotor symptoms of menopause, Approved July 2013
Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013
Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013
Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013.

Medicina Familiar

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013
Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013
Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013
Nesina (alogliptin); Takeda; Para el tratamiento de Diabetes Melitus tipo II, Aprobado Enero 2013
Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013
Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013.


Gastroenterologia


Simponi (golimumab); Janssen Biotech; For the treatment of ulcerative colitis, Aproved May 2013
Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013
Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013.



Enfermedades Geneticas


Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013
Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013
Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; Para e tratamiento de adultos y niños con desorden en en ciclo de la Urea, Aprobado Febrero 2013\

Voluntarios Sanos

Flublok (seasonal influenza vaccine); Protein Sciences; Para la Inmunizacion Activa contra los virus de Influenza subtipos A y B, Aprobado Enero 2013

Hematologia

Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia, Approved July 2013
Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013
Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013
Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013
Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013
Revlimid (lenalidomide); Celgene; For the treatment of mantle cell lymphoma, Approved June 2013
Rixubis (Coagulation Factor IX (Recombinant)]; Baxter International; For the routine prophylaxis and control of hemophilia B, Approved June 2013
Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013  

Inmunologia


Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013
Simponi (golimumab); Janssen Biotech; For the treatment of ulcerative colitis, Aproved May 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013
Tivicay (dolutegravir); ViiV HealthCare; For the treatment of HIV-1 in adults and children over 12 years of age, Approved August 2013
VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013 

Infecciones y Enfermedades Infecciosas


Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013
Vibativ (telavancin); Theravance; For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus, Approved June 2013 

Musculoesqueleticos

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013 

Nefrologia

Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia, Approved July 2013
Procysbi (cysteamine bitartrate); Raptor Pharmaceuticals; For the management of nephropathic cystinosis, Approved May 2013 

Neurologia

Fetzima (levomilnacipran); Forest Labs; For the treatment of major depressive disorder, Approved July 2013
Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013
Trokendi XR (topiramate); Supernus Pharmaceuticals; For the treatment of partial onset, tonic-clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013
Zubsolv (buprenorphine and naloxone); Orexo AB; For the maintenance treatment of opioid dependence, Approved July 2013 

Nutricion y Perdida de Peso


Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013 

Obstetricia/Ginecologia (Salud Femenina)


Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals; For the treatment of vasomotor symptoms of menopause, Approved July 2013
Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013
Lo Minastrin, (norethindrone acetate, ethinyl estradiol, ferrous fumarate); Warner Chilcott; For the prevention of pregnancy, Approved July 2013
Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013 

Oncologia 

Gilotrif (afatinib); Boehringer Ingelheim; For the treatment of metastatic non-small cell lung cancer with EGFR mutations, Approved July 2013
Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013
Mekinist (trametinib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, Approved May of 2013
Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013
Revlimid (lenalidomide); Celgene; For the treatment of mantle cell lymphoma, Approved June 2013
Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013
Tafinlar (dabrafenib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, Approved May 2013
Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013
Xgeva (denosumab); Amgen; For the treatment of giant cell tumor of bone, Approved June 2013
Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013 

Ortopedia/Cirugia Ortopedica


Xgeva (denosumab); Amgen; For the treatment of giant cell tumor of bone, Approved June 2013 

Pediatria/Neonatologia


Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013
Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013
Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013
Tivicay (dolutegravir); ViiV HealthCare; For the treatment of HIV-1 in adults and children over 12 years of age, Approved August 2013
Trokendi XR (topiramate); Supernus Pharmaceuticals; For the treatment of partial onset, tonic-clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013 

Farmacologia/Toxicologia 


Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013 

Psiquiatria/Psicologia


Fetzima (levomilnacipran); Forest Labs; For the treatment of major depressive disorder, Approved July 2013
Zubsolv (buprenorphine and naloxone); Orexo AB; For the maintenance treatment of opioid dependence, Approved July 2013 

Pulmonar/Enfermedades Respiratorias


Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013
Vibativ (telavancin); Theravance; For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus, Approved June 2013 


Reumatologia 

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013 


Trauma (Emergencia, Lesiones, Cirujia)


Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013. 

Urologia

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; Para el tratamiento de Cancer de Prostata co  Metastasis Osea, Aprobado Mayo 2013. 

Vacunas

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

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