2008 FDA Approvals
Degarelix – degarelix – approved 12/24/2008
For the treatment of advanced prostate cancer.
Vasovist® – gadofoveset trisodium – approved 12/22/2008
Imaging agent for use in magnetic resonance angiography (MRA) for examining blood vessels.
Lusedra™ – fospropofol disodium – approved 12/12/2008
A sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult
patients undergoing diagnostic and therapeutic procedures.
Mozobil™ – plerixafor – approved 12/15/2008
For the mobilization of stem cells for autologous transplantationin non-Hodgkin’s lymphoma and multiple myeloma.
Tapentadol – tapentadol – approved 11/20/2008
For the relief of moderate to severe acute pain in adults.
Promacta® – eltrombopag – approved 11/20/2008
For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
Banzel™ – rufinamide – approved 11/14/2008
For the treatment of seizures associated with Lennox-Gastaut syndrome in children and adults.
Toviaz™ – fesoterodine fumarate – approved 10/31/2008
For the treatment of overactive bladder symptoms.
Vimpat® – lacosamide – approved 10/28/2008
Adjunctive therapy for the treatment of partial onset seizures in adults.
Cinryze™ – C1 inhibitor – approved 10/10/2008
For the prevention of angiodema attacks in patients with hereditary angioedema (HAE).
Rapaflo™ – silodosin – approved 10/8/2008
For the treatment of of benign prostatic hyperplasia (BHP).
AdreView™ – Iobenguane I-123 – approved 9/19/2008
Molecular imaging agent for use in the detection of neuroendocrine tumors.
Nplate™ – romiplostim – approved 8/22/2008
For the long-term treatment of adult chronic immune (idiopathic) thrombocytopenic purpura (ITP).
Xenazine® – tetrabenazine – approved 8/15/2008
For the treatment of chorea associated with Huntington’s disease.
Fluarix® – virus vaccine – approved 8/5/2008
For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B.
Fluvirin® – influenza virus vaccine – approved 8/1/2008
For immunization of persons 4 years of age and older against influenza virus disease caused by influenza virus subtypes A and type B contained in the vaccine.
Cleviprex® – clevidipine butyrate – approved 8/1/2008
Intravenous therapy for the treatment of high blood pressure when oral therapy is not feasible.
Afluria® – influenza virus vaccine – approved 7/30/2008
For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
FluLaval™ – influenza virus vaccine – approved 7/28/2008
For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
FluMist® – influenza virus vaccine, live, intranasal – approved 7/25/2008
For the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
Fluzone® – influenza virus vaccine – approved 7/14/2008
For active immunization in persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
Eovist® – gadoxetate disodium – approved 7/3/2008
For intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.
Kinrix™ – Diphtheria and Tetanus toxoids and Acellular Pertussis adsorbed, inactivated poliovirus – approved 6/24/2008
For active immunization against diphtheria, tetanus, pertussis, poliomyelitis as the5th dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the 4th dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the 4th dose.
Durezol™ – difluprednate – approved 6/23/2008
For the treatment of inflammation and pain associated with ocular surgery.
Pentacel® – Diphtheria and Tetanus toxoids and Acellular Pertussis adsorbed, inactivated poliovirus and Haemophilus b Conjugate vaccine – approved 6/20/2008
For active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to 5th birthday).
Entereg® – alvimopan – approved 5/20/2008
For accelerating the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery.
Relistor™ – methylnaltrexone bromide – approved 4/24/2008
For restoring bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate pain.
Cimzia® – certolizumab pegol – approved 4/22/2008
For adults with moderate to severe Crohn's disease who have not responded to conventional therapies.
Lexiscan™ – regadenoson – approved 4/10/2008
For use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI) – a test that detects and characterizes coronary artery disease – in patients unable to undergo adequate exercise stress.
Treanda® – bendamustin hydrochloride – approved 3/20/2008
For treatment of chronic lymphocytic leukemia.
Rotarix® – rotavirus vaccine, live – approved 3/19/2008
For the prevention of rotavirus, which can cause gastroenteritis, in infants and children.
Artiss – fibrin sealant – approved 3/19/2008
For use in adhering skin grafts in adult and pediatric (human) burn patients.
Pristiq™ – desvenlafaxine succinate – approved 2/29/2008
For the treatment of major depressive disorder.
Arcalyst™ – rilonacept – approved 2/27/2008
For the long-term treatment of two Cryopyrin-Associated Periodic Syndromes disorders: Familial Cold Auto-Inflammatory Syndrome and Muckle-Wells Syndrome.
Xyntha™ – antihemophilic factor (recombinant), plasma, albumin-free – approved 2/21/2008
For the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in patients diagnosed with hemophilia A, also used to help prevent surgical bleeding in this patient population.
Intelence™ – etavirine – approved 1/18/2008
For the treatment of HIV in adults who have failed treatment with other antiretrovirals.
Recothrom™– thrombin – approved 1/17/2008
Treatment to stop small blood vessels from bleeding after surgery
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