[转移帖]2010年FDA批准的药物清单

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原帖由论坛会员Rojjer发表于 2010-12-30 15:01

Cardiology/Vascular Diseases

Pradaxa (dabigatran etexilate mesylate); Boehringer Ingeleheim; For the risk reduction of stroke and embolism due to atrial fibrillation, Approved October 2010

Tekamlo (aliskiren + amlodipine); Novartis; For the treatment of hypertension, Approved August 2010

Tribenzor (olmesartan medoxomil + amlodipine + hydrochlorothiazide); Daiichi Sankyo; For the treatment of hypertension, Approved July 2010

Dermatology/Plastic Surgery
Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010

Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010

Zyclara (imiquimod); Graceway; For the treatment of actinic keratoses of the face and scalp, Approved March 2010

Endocrinology
Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010

Victoza (liraglutide); Novo Nordisk; For the treatment of type 2 diabetes mellitus, Approved January 2010

Gastroenterology
Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010

Pancreaze (pancrelipase); Johnson & Johnson; For the treatment of exocrine pancreatic insufficiency, Approved April of 2010

Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010

Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010

Hematology
Vpriv (velaglucerase alfa for injection); Shire; For the treatment of type 1 Gaucher disease, Approved March 2010

Immunology/Infectious Diseases
Cayston (aztreonam for inhalation solution); Gilead Sciences; For the treatment of cystic fibrosis patients with Pseudomonas aeruginosa, Approved February 2010

Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, Approved November 2010

Menveo (meningitis vaccine); Novartis; For the active immunization to prevent invasive meningococcal disease, Approved February 2010

Oravig (miconazole); Strativa Pharmaceuticals; oropharyngeal candidiasis, Approved April 2010

Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine); Wyeth; For the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae, Approved February 2010

Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010

Zortress (everolimus); Novartis; For the prevention of organ rejection following kidney transplant, Approved May 2010

Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial conjunctivitis, Approved May 2010

Musculoskeletal
Actemra (tocilizumab); Genentech; For the treatment of rheumatoid arthritis, Approved January 2010

Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple sclerosis, Approved January 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March 2010

Gilenya (fingolimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved September 2010

Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia), Approved September 2010

Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010

Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010

Xeomin (incobotulinumtoxinA); Merz Pharmaceutical; For the treatment of cervical dystonia and blepharospasm, Approved July 2010

Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone metastases from solid tumors, Approved November 2010

Xiaflex (collagenase clostridium histolyticum); Auxilium Pharmaceuticals; For the treatment of Dupuytren’s contracture, Approved February 2010

Nephrology/Urology
Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved March 2010

Jalyn (dutasteride + tamsulosin); GlaxoSmithKline; For the treatment of benign prostatic hyperplasia, Approved June 2010

Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010

Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 2010

Xifaxan (rifaximin); Salix; For the treatment of hepatic encephalopathy, Approved March 2010

Zortress (everolimus); Novartis; For the prevention of organ rejection following kidney transplant, Approved May 2010

Neurology
Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple sclerosis, Approved January 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of chronic migraine, Approved October 2010

Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved March 2010

Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics with neurologic conditions, Approved July 2010

Exalgo (hydromorphone hydrochloride) extended release; Alza; For the management of moderate to severe pain, Approved March 2010

Kapvay (clonidine hydrochloride); Shionogi Pharma; For the treatment of attention deficit hyperactivity disorder, Approved October 2010

Nuedexta (dextromethorphan hydrobromide and quinidine sulfate); Avanir Pharmaceuticals; For the treatment of pseudobulbar affect, Approved October 2010

Silenor (doxepin); Somaxon Pharma; For the treatment of insomnia, Approved March 2010

Sprix (ketorolac tromethamine); Roxro Pharma; For the treatment of moderate to severe pain, Approved May 2010

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the prevention of relapse to opioid dependence, Approved October 2010

Vpriv (velaglucerase alfa for injection); Shire; For the treatment of type 1 Gaucher disease, Approved March 2010

Xifaxan (rifaximin); Salix; For the treatment of hepatic encephalopathy, Approved March 2010

Obstetrics/Gynecology
ella (ulipristal acetate); HRA Pharma; For the emergency prevention of contraception, Approved August 2010

Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010

Natazia (estradiol valerate + dienogest); Bayer; For the prevention of contraception, Approved May 2010

Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010

Oncology
Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010

Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010

Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010

Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 2010

Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone metastases from solid tumors, Approved November 2010

Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010

Ophthalmology
Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial conjunctivitis, Approved May 2010

Otolaryngology
Oravig (miconazole); Strativa Pharmaceuticals; oropharyngeal candidiasis, Approved April 2010

Pediatrics/Neonatology
Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics with neurologic conditions, Approved July 2010

Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of asthma, Approved June 2010

Kapvay (clonidine hydrochloride); Shionogi Pharma; For the treatment of attention deficit hyperactivity disorder, Approved October 2010

Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010

Pharmacology/Toxicology
Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, Approved November 2010

Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010

Psychiatry/Psychology
Latuda (lurasidone); Sunovion; For the treatment of schizophrenia, Approved October 2010

Oleptro (trazodone hydrochloride); Labopharm; For the treatment of major depressive disorder, Approved February 2010

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the prevention of relapse to opioid dependence, Approved October 2010

Pulmonary/Respiratory Diseases
Cayston (aztreonam for inhalation solution); Gilead Sciences; For the treatment of cystic fibrosis patients with Pseudomonas aeruginosa, Approved February 2010

Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of asthma, Approved June 2010

Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010

Rheumatology
Actemra (tocilizumab); Genentech; For the treatment of rheumatoid arthritis, Approved January 2010

Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia), Approved September 2010

Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010

Trauma/Emergency Medicine
Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010


http://www.centerwatch.com/drug-information/fda-approvals/