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 8, 93-96 (February 2009)

doi:10.1038/nrd2813

Generic name (Trade name)	Company*	Indication(URL of label information if available)	Properties	Date
Etravirine (Intelence)	Tibotec	HIV-1(http://www.fda.gov/cder/foi/label/2008/022187lbl.pdf)	Non-nucleoside reverse transcriptase inhibitor	18 Jan (P)
Desvenlafaxine (Pristiq)	Wyeth	Major depressive disorder(http://www.fda.gov/cder/foi/label/2008/021992lbl.pdf)	Selective serotonin and noradrenaline reuptake inhibitor	29 Feb (S)
Bendamustine hydrochloride (Treanda)	Cephalon	Chronic lymphocytic leukaemia(http://www.fda.gov/cder/foi/label/2008/022249lbl.pdf)	Mechlorethamine derivative with DNA-alkylating activity	20 Mar (P, O)
Regadenoson (Lexiscan)	CV Therapeutics	Pharmacological stress agent for radionuclide imaging (http://www.fda.gov/cder/foi/label/2008/022161lbl.pdf)	A2A adenosine receptor agonist	10 Apr (S)
Methylnaltrexone bromide (Relistor)	Progenics	Opioid-induced constipation	Peripherally acting  opioid receptor antagonist	24 Apr (S)
Alvimopan (Entereg)	Adolor	To accelerate gastrointestinal recovery following bowel resection surgery(http://www.fda.gov/cder/foi/label/2008/021775lbl.pdf)	Peripherally acting  opioid receptor antagonist	20 May (S)
Difluprednate (Durezol)	Sirion	Inflammation 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 proteins	23 Jun (P)
Gadoxetate disodium (Eovist)	Bayer	Gadolinium-based contrast agent(http://www.fda.gov/cder/foi/label/2008/022090lbl.pdf)	Paramagnetic compound	3 Jul (S)
Clevidipine butyrate (Cleviprex)	The Medicines Company	Peri-operative hypertension when oral therapy is not feasible or not desirable	Short-acting dihydropyridine calcium channel antagonist	1 Aug (S)
Tetrabenazine (Xenazine)	Prestwick	Chorea associated with Huntington's disease(http://www.fda.gov/cder/foi/label/2008/021894lbl.pdf)	Monoamine-depleting agent	15 Aug (P, O)
Iobenguane I-123 (AdreView)	GE Healthcare	Radiopharmaceutical 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 terminals	19 Sep (P, O)
Silodosin (Rapaflo)	Watson	Benign prostatic hyperplasia(http://www.fda.gov/cder/foi/label/2008/022206lbl.pdf)	1 adrenoceptor antagonist	8 Oct (S)
Lacosamide (Vimpat)	Schwarz	Partial-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 2	28 Oct (S)
Fesoterodine fumarate (Toviaz)	Pfizer	Overactive bladder disorder(http://www.fda.gov/cder/foi/label/2008/022030lbl.pdf)	Competitive muscarinic receptor antagonist	31 Oct (S)
Rufinamide (Banzel)	Eisai	Seizures associated with Lennox–Gastaut syndrome (http://www.fda.gov/cder/foi/label/2008/021911lbl.pdf)	Sodium channel activity modulator	14 Nov (S)
Eltrombopag (Promacta)	GlaxoSmithKline	Thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (http://www.fda.gov/cder/foi/label/2008/022291lbl.pdf)	Thrombopoietin receptor agonist	20 Nov (P, O)
Tapentadol hydrochloride‡	Ortho–McNeil–Janssen	Moderate to severe acute pain	opioid receptor agonist and noradrenaline reuptake inhibitor	20 Nov (S)
Fospropofol disodium (Lusedra)	Eisai	Monitored anaesthesia care sedation (http://www.fda.gov/cder/foi/label/2008/022244lbl.pdf)	Prodrug of propofol	12 Dec (S)
Plerixafor (Mozobil)	Genzyme	Autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma (http://www.fda.gov/cder/foi/label/2008/022311lbl.pdf)	CXCR4 antagonist	15 Dec (P, O)
Gadofosveset (Vasovist)	Epix	Gadolinium-based contrast agent	Paramagnetic compound	22 Dec (S)
Degarelix (Firmagon)	Ferring	Advanced prostate cancer (http://www.fda.gov/cder/foi/label/2008/022201lbl.pdf)	Gonadotropin-releasing hormone receptor antagonist	24 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.