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Friday, February 27, 2009

New molecular entities approved by the US FDA's Center for Drug Evaluation and Research in 2008

FROM THE FOLLOWING ARTICLE:

2008 FDA drug approvals

Bethan Hughes

Nature Reviews Drug Discovery 893-96 (February 2009)

doi:10.1038/nrd2813

Generic name (Trade name)Company*Indication(URL of label information if available)PropertiesDate
Etravirine (Intelence)TibotecHIV-1(http://www.fda.gov/cder/foi/label/2008/022187lbl.pdf)Non-nucleoside reverse transcriptase inhibitor18 Jan (P)
Desvenlafaxine (Pristiq)WyethMajor depressive disorder(http://www.fda.gov/cder/foi/label/2008/021992lbl.pdf)Selective serotonin and noradrenaline reuptake inhibitor29 Feb (S)
Bendamustine hydrochloride (Treanda)CephalonChronic lymphocytic leukaemia(http://www.fda.gov/cder/foi/label/2008/022249lbl.pdf)Mechlorethamine derivative with DNA-alkylating activity20 Mar (P, O)
Regadenoson (Lexiscan)CV TherapeuticsPharmacological stress agent for radionuclide imaging (http://www.fda.gov/cder/foi/label/2008/022161lbl.pdf)A2A adenosine receptor agonist10 Apr (S)
Methylnaltrexone bromide (Relistor)ProgenicsOpioid-induced constipationPeripherally acting mu opioid receptor antagonist24 Apr (S)
Alvimopan (Entereg)AdolorTo accelerate gastrointestinal recovery following bowel resection surgery(http://www.fda.gov/cder/foi/label/2008/021775lbl.pdf)Peripherally acting mu opioid receptor antagonist20 May (S)
Difluprednate (Durezol)SirionInflammation and pain associated with ocular surgery (http://www.fda.gov/cder/foi/label/2008/022212lbl.pdf)Ocular corticosteroid thought to act by the induction of phospholipase A2 inhibitory proteins23 Jun (P)
Gadoxetate disodium (Eovist)BayerGadolinium-based contrast agent(http://www.fda.gov/cder/foi/label/2008/022090lbl.pdf)Paramagnetic compound3 Jul (S)
Clevidipine butyrate (Cleviprex)The Medicines CompanyPeri-operative hypertension when oral therapy is not feasible or not desirableShort-acting dihydropyridine calcium channel antagonist1 Aug (S)
Tetrabenazine (Xenazine)PrestwickChorea associated with Huntington's disease(http://www.fda.gov/cder/foi/label/2008/021894lbl.pdf)Monoamine-depleting agent15 Aug (P, O)
Iobenguane I-123 (AdreView)GE HealthcareRadiopharmaceutical agent for the detection of primary or metastatic phaeochromocytoma or neuroblastoma (http://www.fda.gov/cder/foi/label/2008/22290lbl.pdf)Taken up by the noradrenaline transporter in adrenergic nerve terminals19 Sep (P, O)
Silodosin (Rapaflo)WatsonBenign prostatic hyperplasia(http://www.fda.gov/cder/foi/label/2008/022206lbl.pdf)alpha1 adrenoceptor antagonist8 Oct (S)
Lacosamide (Vimpat)SchwarzPartial-onset seizures in epilepsy (http://www.fda.gov/cder/foi/label/2008/022253lbl.pdf)Selectively enhances slow inactivation of voltage-gated sodium channels and binds to collapsin response mediator protein 228 Oct (S)
Fesoterodine fumarate (Toviaz)PfizerOveractive bladder disorder(http://www.fda.gov/cder/foi/label/2008/022030lbl.pdf)Competitive muscarinic receptor antagonist31 Oct (S)
Rufinamide (Banzel)EisaiSeizures associated with Lennox–Gastaut syndrome (http://www.fda.gov/cder/foi/label/2008/021911lbl.pdf)Sodium channel activity modulator14 Nov (S)
Eltrombopag (Promacta)GlaxoSmithKlineThrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (http://www.fda.gov/cder/foi/label/2008/022291lbl.pdf)Thrombopoietin receptor agonist20 Nov (P, O)
Tapentadol hydrochlorideOrtho–McNeil–JanssenModerate to severe acute painmu opioid receptor agonist and noradrenaline reuptake inhibitor20 Nov (S)
Fospropofol disodium (Lusedra)EisaiMonitored anaesthesia care sedation (http://www.fda.gov/cder/foi/label/2008/022244lbl.pdf)Prodrug of propofol12 Dec (S)
Plerixafor (Mozobil)GenzymeAutologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma (http://www.fda.gov/cder/foi/label/2008/022311lbl.pdf)CXCR4 antagonist15 Dec (P, O)
Gadofosveset (Vasovist)EpixGadolinium-based contrast agentParamagnetic compound22 Dec (S)
Degarelix (Firmagon)FerringAdvanced prostate cancer (http://www.fda.gov/cder/foi/label/2008/022201lbl.pdf)Gonadotropin-releasing hormone receptor antagonist24 Dec (S)
*The company that submitted the original new drug application to the US FDA.Trade name not available at the time of going to press. O, FDA orphan designation; P, FDA priority review; S, FDA standard review.

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