As an FDA Retiree(previously involved with approval of new drugs), I am still interested on new drugs approved recently by FDA. Here is list from Center Watch. Note that there are no new anti-infected drugs in the list. Visit, www.fda.gov for the latest news on drug development and research.
Cardiology/Vascular DiseasesEdarbi (azilsartan medoxomil); Takeda; For the treatment of hypertension, Approved February 2011
Dermatology/Plastic SurgeryGralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 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
Endocrinology
Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 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
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
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
Immunology/Infectious Diseases
Benlysta (belimumab); Human Genome Sciences; For the treatment of systemic lupus erythematosus, Approved March 2011
Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011
Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved May 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
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
Neurology
Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 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
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
Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 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
Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011
Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May 2011
OtolaryngologyVandetanib (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
Psychiatry/Psychology
Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011
Pulmonary/Respiratory Diseases
Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 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
Source: Center Watch
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