Cardiology/Vascular Diseases
Adcirca (tadalafil) ; Eli Lilly; For the treatment of pulmonary arterial hypertension, Approved May 2009
Atryn (antithrombin recombinant lyophilized powder for reconstitution) ; GTC BioTherapeutics; For the prevention of peri-operative and peri-partum thromboembolic events, Approved January 2009
Efient (prasugrel) ; Eli Lilly; for the prevention of thrombotic cardiovascular complications in acute coronary syndromes, Approved July 2009
Livalo (pitavastatin) ; Kowa Company; For the treatment of primary hyperlipidemia and mixed dyslipidemia, Approved August 2009
Multaq (dronedarone) ; Sanofi-aventis; For the treatment of paroxysmal or persistent atrial fibrillation or atrial flutter, Approved July 2009
Tyvaso (treprostinil) ; United Therapeutics; For the treatment of pulmonary arterial hypertension, Approved July 2009
Dermatology/Plastic Surgery
Stelara (ustekinumab) ; Centocor Ortho Biotech; For the treatment of plaque psoriasis, Approved September 2009
Vibativ (telavancin) ; Theravance; For the treatment of complicated skin and skin structure infections, Approved September 2009
Endocrinology
Cycloset, bromocriptine mesylate ; VeroScience; For the treatment of type 2 diabetes mellitus, Approved May 2009
Onglyza (saxagliptin) ; Bristol-Myers Squibb; For the treatment of type 2 diabetes mellitus, Approved July 2009
Gastroenterology
Metozolv ODT (metoclopramide hydrochloride) ; Salix Pharmaceuticals; For the treatment of gastroesophageal reflux and diabetic gastroparesis, Approved September of 2009
Zenpep (pancrelipase) ; Eurand; For the treatment of pancreatic insufficiency due to cystic fibrosis or other conditions, Approved August 2009
Hematology
Arzerra (ofatumumab) ; GlaxoSmithKline; For the treatment of chronic lymphocytic leukemia, Approved October 2009
Atryn (antithrombin recombinant lyophilized powder for reconstitution) ; GTC BioTherapeutics; For the prevention of peri-operative and peri-partum thromboembolic events, Approved January 2009
Efient (prasugrel) ; Eli Lilly; for the prevention of thrombotic cardiovascular complications in acute coronary syndromes, Approved July 2009
Elitek (rasburicase) ; sanofi-aventis; For the management of plasma uric acid levels in adults with malignancies, Approved October 2009
Feraheme (ferumoxytol) ; AMAG; For the treatment of iron deficiency anemia associated with chronic kidney disease, Approved June 2009
Folotyn (pralatrexate injection) ; Allos Therapeutics; For the treatment of peripheral T-cell lymphoma, Approved September 2009
Istodax (romidepsin) ; Gloucester Pharmaceuticals; For the treatment of cutaneous T-cell lymphoma, Approved November 2009
Samsca (tolvaptan) ; Otsuka; For the treatment of hyponatremia, Approved May of 2009
Immunology/Infectious Diseases
Bepreve (bepotastine besilate ophthalmic solution) ; Ista Pharmaceuticals; For the treatment of itching associated with allergic conjunctivitis, Approved September 2009
Berinert (C1 Esterase Inhibitor (Human)) ; CSL Behring; For the treatment of abdominal or facial attacks of hereditary angioedema, Approved October 2009
Besivance (besifloxacin ophthalmic suspension) ; Bausch & Lomb; For the treatment of bacterial conjunctivitis, Approved June 2009
Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant ; GlaxoSmithKline; For the prevention of cervical cancer and cervical intraepithelial neoplasia caused by HPV types 16 and 18, Approved October 2009
Coartem (artemether/lumefantrine) ; Novartis; For the treatment of malaria infections due to Plasmodium falciparum, Approved April 2009
Hiberix (Haemophilus b Conjugate Vaccine; Tetanus Toxoid Conjugate) ; GlaxoSmithKline; For the prevention of invasive disease caused by Haemophilus influenzae type b., August of 2009
Ilaris (canakinumab) ; Novartis; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved June 2009
Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) ; Intercell AG; For the prevention of disease caused by Japanese encephalitis virus, Approved March 2009
Qutenza (capsaicin) ; NeurogesX; For the treatment of neuropathic pain associated with postherpetic neuralgia, Approved November 2009
Vibativ (telavancin) ; Theravance; For the treatment of complicated skin and skin structure infections, Approved September 2009
Zirgan (ganciclovir ophthalmic gel) ; Sirion Therapeutics; For the treatment of acute herpetic keratitis, Approved September 2009
Musculoskeletal
Cimzia (certolizumab pegol) ; UCB; For the treatment of rheumatoid arthritis, Approved May of 2009
Colcrys (colchicine) ; Mutual Pharmaceuticals; For gout flares and familial Mediterranean fever, Approved October 2009
Extavia (Interferon beta-l b) ; Novartis; For the treatment of relapsing multiple sclerosis, Approved August of 2009
Pennsaid (diclofenac sodium topical solution) ; Nuvo Research; For the treatment of osteoarthritis of the knee, Approved November 2009
Sabril (vigabatrin) ; Lundbeck, Inc.; For the treatment of infantile spasms and complex partial seizures, Approved August 2009
Savella (milnacipran hydrochloride) ; Forest Laboratories; For the treatment of fibromyalgia, Approved January 2009
Simponi (golimumab) ; Centocor Ortho Biotech; For the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, Approved April 2009
Nephrology/Urology
Afinitor (everolimus) ; Novartis; For the treatment of renal cell carcinoma, Approved March 2009
Avastin (bevacizumab) ; Genentech; For the treatment of renal cell carcinoma, Approved July 2009
Feraheme (ferumoxytol) ; AMAG; For the treatment of iron deficiency anemia associated with chronic kidney disease, Approved June 2009
Gelnique (oxybutynin chloride) ; Watson Pharmaceuticals; For the treatment of overactive bladder, Approved January 2009
Votrient (pazopanib) ; GlaxoSmithKline; For the treatment of renal cell carcinoma, Approved October of 2009
Neurology
Axona (caprylidene) ; Accera; For the treatment of Alzheimer's disease, Approved March 2009
Cambia (diclofenac potassium for oral solution) ; Kowa Pharmaceuticals; For the treatment of migraine attacks, Approved June of 2009
Edluar (zolpidem tartrate) ; Orexo; For the treatment of insomnia, Approved March 2009
Embeda (morphine sulfate and naltrexone hydrochloride) ; King Pharmaceuticals; For the treatment of moderate to severe pain, Approved August of 2009
Extavia (Interferon beta-l b) ; Novartis; For the treatment of relapsing multiple sclerosis, Approved August of 2009
Intuniv (guanfacine extended-release) ; Shire; For the treatment of ADHD in children and adolescents, Approved September 2009
Onsolis (fentanyl buccal) ; BioDelivery Sciences; For the management of breakthrough cancer pain, Approved July 2009
Qutenza (capsaicin) ; NeurogesX; For the treatment of neuropathic pain associated with postherpetic neuralgia, Approved November 2009
Sabril (vigabatrin) ; Lundbeck, Inc.; For the treatment of infantile spasms and complex partial seizures, Approved August 2009
Zipsor (diclofenac potassium) ; Xanodyne; For the treatment of mild to moderate acute pain, Approved June 2009
Obstetrics/Gynecology
Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant ; GlaxoSmithKline; For the prevention of cervical cancer and cervical intraepithelial neoplasia caused by HPV types 16 and 18, Approved October 2009
Lysteda (tranexamic acid) ; Xanodyne Pharmaceuticals; For the treatment of heavy menstrual bleeding, Approved November 2009
Oncology
Afinitor (everolimus) ; Novartis; For the treatment of renal cell carcinoma, Approved March 2009
Arzerra (ofatumumab) ; GlaxoSmithKline; For the treatment of chronic lymphocytic leukemia, Approved October 2009
Avastin (bevacizumab) ; Genentech; For the treatment of renal cell carcinoma, Approved July 2009
Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant ; GlaxoSmithKline; For the prevention of cervical cancer and cervical intraepithelial neoplasia caused by HPV types 16 and 18, Approved October 2009
Elitek (rasburicase) ; sanofi-aventis; For the management of plasma uric acid levels in adults with malignancies, Approved October 2009
Folotyn (pralatrexate injection) ; Allos Therapeutics; For the treatment of peripheral T-cell lymphoma, Approved September 2009
Istodax (romidepsin) ; Gloucester Pharmaceuticals; For the treatment of cutaneous T-cell lymphoma, Approved November 2009
Onsolis (fentanyl buccal) ; BioDelivery Sciences; For the management of breakthrough cancer pain, Approved July 2009
Votrient (pazopanib) ; GlaxoSmithKline; For the treatment of renal cell carcinoma, Approved October of 2009
Ophthalmology
Acuvail (ketorolac tromethamine) ; Allergan; For the treatment of pain and inflammation following cataract surgery., Approved July 2009
Bepreve (bepotastine besilate ophthalmic solution) ; Ista Pharmaceuticals; For the treatment of itching associated with allergic conjunctivitis, Approved September 2009
Besivance (besifloxacin ophthalmic suspension) ; Bausch & Lomb; For the treatment of bacterial conjunctivitis, Approved June 2009
Ozurdex (dexamethasone) ; Allergan; For the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion, Approved June 2009
Zirgan (ganciclovir ophthalmic gel) ; Sirion Therapeutics; For the treatment of acute herpetic keratitis, Approved September 2009
Pediatrics/Neonatology
Berinert (C1 Esterase Inhibitor (Human)) ; CSL Behring; For the treatment of abdominal or facial attacks of hereditary angioedema, Approved October 2009
Colcrys (colchicine) ; Mutual Pharmaceuticals; For gout flares and familial Mediterranean fever, Approved October 2009
Hiberix (Haemophilus b Conjugate Vaccine; Tetanus Toxoid Conjugate) ; GlaxoSmithKline; For the prevention of invasive disease caused by Haemophilus influenzae type b., August of 2009
Ilaris (canakinumab) ; Novartis; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved June 2009
Intuniv (guanfacine extended-release) ; Shire; For the treatment of ADHD in children and adolescents, Approved September 2009
Sabril (vigabatrin) ; Lundbeck, Inc.; For the treatment of infantile spasms and complex partial seizures, Approved August 2009
Psychiatry/Psychology
Edluar (zolpidem tartrate) ; Orexo; For the treatment of insomnia, Approved March 2009
Fanapt (iloperidone) ; Vanda; For the treatment of schizophrenia, Approved May of 2009
Intuniv (guanfacine extended-release) ; Shire; For the treatment of ADHD in children and adolescents, Approved September 2009
Saphris (asenapine) ; Schering-Plough; For the treatment of schizophrenia and manic or mixed bipolar 1 episodes, Approved August of 2009
Pulmonary/Respiratory Diseases
Adcirca (tadalafil) ; Eli Lilly; For the treatment of pulmonary arterial hypertension, Approved May 2009
Tyvaso (treprostinil) ; United Therapeutics; For the treatment of pulmonary arterial hypertension, Approved July 2009
Rheumatology
Cimzia (certolizumab pegol) ; UCB; For the treatment of rheumatoid arthritis, Approved May of 2009
Colcrys (colchicine) ; Mutual Pharmaceuticals; For gout flares and familial Mediterranean fever, Approved October 2009
Pennsaid (diclofenac sodium topical solution) ; Nuvo Research; For the treatment of osteoarthritis of the knee, Approved November 2009
Simponi (golimumab) ; Centocor Ortho Biotech; For the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, Approved April 2009
Uloric (febuxostat) ; Takeda; For the treatment of chronic hyperuricemia in patients with gout, Approved February 2009
Trauma/Emergency Medicine
Atryn (antithrombin recombinant lyophilized powder for reconstitution) ; GTC BioTherapeutics; For the prevention of peri-operative and peri-partum thromboembolic events, Approved January 2009
转载自CenterWatch
