Tuesday, February 21, 2012

Drugs Approved by US-FDA in 2011: A Glance

Cardiology/Vascular Diseases

Brilinta (ticagrelor); AstraZeneca; For the reduction of thrombotic events in patients with acute coronary syndrome, Approved July 2011

Edarbi (azilsartan medoxomil); Takeda; For the treatment of hypertension, Approved February 2011

Edarbyclor (azilsartan medoxomil and chlorthalidone); Takeda Pharmaceutical; For the treatment of hypertension, Approved December of 2011

Xarelto (rivaroxaban); Janssen Pharmaceuticals; For the reduction in the risk of stroke and systemic embolism resulting from atrial fibrillation, Approved November 2011

Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery, Approved July 2011

Dermatology/Plastic Surgery

Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011

laViv (azficel-T); Fibrocell Science; For the improvement of nasolabial fold wrinkles in adults, Approved June 2011

Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011

Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011

Endocrinology

Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Juvisync (sitagliptin and simvastatin); Merck; For the treatment of type II diabetes, Approved October 2011

Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of type II diabetes, Approved May 2011

Gastroenterology

Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011

Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011

Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Rectiv (nitroglycerin) ointment 0.4%; ProStrakan; For the treatment of chronic anal fissure, Approved June 2011

Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

Hematology

Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, Approved August 2011

Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute lymphoblastic leukemia, Approved November of 2011

Ferriprox (deferiprone); Apotex; For the treatment of transfusional iron overload due to thalassemia, Approved October 2011

Jakafi (ruxolitinib); Incyte; For the treatment of myelofibrosis, Approved November 2011

Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011

Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery, Approved July 2011

Immunology/Infectious Diseases

Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011

Benlysta (belimumab); Human Genome Sciences; For the treatment of systemic lupus erythematosus, Approved March 2011

Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 in treatment-naive adults, Approved August of 2011

Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011

Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011

Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved May 2011

Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011

Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011

Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

Musculoskeletal

Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011

Nephrology/Urology

Anturol (oxybutynin) Gel; Antares Pharma; For the treatment of overactive bladder, Approved December 2011

Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011

Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011

Neurology

Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011

Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical analgesia, Approved November 2011

Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of restless legs syndrome, Approved April 2011

Intermezzo (zolpidem tartrate sublingual tablet); Transcept Pharmaceuticals; For the treatment of insomnia, Approved November 2011

Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011

Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011

Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011

Potiga (ezogabine); Valeant Pharmaceuticals; For the treatment of partial-onset seizures, Approved June 2011

Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011

Obstetrics/Gynecology

Makena (hydroxyprogesterone caproate injection); Hologic; For the prevention of risk of preterm birth, Approved February 2011

Oncology

Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011

Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, Approved August 2011

Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute lymphoblastic leukemia, Approved November of 2011

Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011

Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011

Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011

Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011

Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May 2011

Ophthalmology

Eylea (aflibercept); Regeneron Pharmaceuticals; For the treatment of neovascular (wet) age-related macular degeneration, Approved November 2011

Otolaryngology

Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011

Pediatrics/Neonatology

Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011

Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011

Pharmacology/Toxicology

Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011

Psychiatry/Psychology

Intermezzo (zolpidem tartrate sublingual tablet); Transcept Pharmaceuticals; For the treatment of insomnia, Approved November 2011

Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011

Pulmonary/Respiratory Diseases

Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011

Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011

Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Rheumatology

Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011

Trauma/Emergency Medicine

Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical analgesia, Approved November 2011

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