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FDA Approvals

These briefs highlight critical information including recommended dosing, pharmacokinetics, clinical applications, and other need-to-know facts. The following information is intended for use by competent health care professionals and academia. You assume full responsibility for ensuring the appropriate use and reliance upon this information.

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2010 U.S. FDA Drug Approvals

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (approved February 3)

LIRAGLUTIDE (approved January 25)

DALFAMPRIDINE (approved January 22)

TOCILIZUMAB (approved January 8)

PREGABALIN (approved January 4)

2009 U.S. FDA Drug Approvals

TELAVANCIN HYDROCHLORIDE (approved December 15)

ECALLANTIDE (approved November 27)

CAPSAICIN (approved November 16)

TRANEXAMIC ACID (approved November 13)

ROMIDEPSIN (approved November 5)

OFATUMUMAB (approved October 27)

PAZOPANIB HYDROCHLORIDE (approved October 19)

HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE BIVALENT (TYPES 16, 18) (approved October 16)

USTEKINUMAB (approved September 25)

PRALATREXATE (approved September 24)

INFLUENZA A VIRUS VACCINE, H1N1, INACTIVATED (approved September 15)

INFLUENZA A VIRUS VACCINE, H1N1, LIVE (approved September 15)

BEPOTASTINE BESILATE (approved September 8)

VIGABATRIN (approved August 21)

MORPHINE SULFATE/NALTREXONE HYDROCHLORIDE (approved August 13)

ASENAPINE (approved August 13)

PITAVASTATIN CALCIUM (approved August 3)

SAXAGLIPTIN HYDROCHLORIDE (approved July 31)

PALIPERIDONE PALMITATE (approved July 31)

PRASUGREL HYDROCHLORIDE (approved July 10)

DRONEDARONE HYDROCHLORIDE (approved July 1)

FERUMOXYTOL (approved June 30)

DEXAMETHASONE (approved June 19)

CANAKINUMAB (approved June 19)

BESIFLOXACIN HYDROCHLORIDE (approved May 28)

ILOPERIDONE (approved May 6)

BROMOCRIPTINE MESYLATE (approved May 5)

ABOBOTULINUMTOXINA (approved April 30)

GOLIMUMAB (approved April 24)

ARTEMETHER/LUMEFANTRINE (approved April 7)

JAPANESE ENCEPHALITIS VACCINE, INACTIVATED, ADSORBED (approved March 30)

EVEROLIMUS (approved March 30)

FEBUXOSTAT (approved February 13)

OXYBUTYNIN CHLORIDE (approved January 27)

FIBRINOGEN CONCENTRATE (HUMAN) (approved January 16)

MILNACIPRAN HYDROCHLORIDE (approved January 14)

TAPENTADOL HYDROCHLORIDE (approved November 20)

2008 U.S. FDA Drug Approvals

PLERIXAFOR (approved December 15)

FENOFIBRIC ACID (approved December 15)

FOSPROPOFOL DISODIUM (approved December 12)

ELTROMBOPAG (approved November 20)

RUFINAMIDE (approved November 14)

FESOTERODINE FUMARATE (approved October 31)

LACOSAMIDE (approved October 29)

C1 ESTERASE INHIBITOR, HUMAN (approved October 10)

SILODOSIN (approved October 8)

ROMIPLOSTIM (approved August 22)

TETRABENAZINE (approved August 15)

CLEVIDIPINE BUTYRATE (approved August 4)

DIFLUPREDNATE (approved June 23)

ALVIMOPAN (approved May 20)

METHYLNALTREXONE BROMIDE (approved April 24)

CERTOLIZUMAB PEGOL (approved April 22)

REGADENOSON (approved April 10)

BENDAMUSTINE HYDROCHLORIDE (approved March 20)

LEVOLEUCOVORIN CALCIUM (approved March 7)

DESVENLAFAXINE SUCCINATE (approved February 29)

RILONACEPT (approved February 27)

FOSAPREPITANT DIMEGLUMINE (approved January 25)

ETRAVIRINE (approved January 18)

THROMBIN HUMAN, RECOMBINANT (approved January 17)

2007 U.S. FDA Drug Approvals

SAPROPTERIN DIHYDROCHLORIDE (approved December 13)

NEBIVOLOL HYDROCHLORIDE (approved December 1)

METHOXY POLYETHYLENE GLYCOLEPOETIN BETA (approved November 14)

NILOTINIB HYDROCHLORIDE (approved October 29)

IXABEPILONE (approved October 16)

DORIPENEM (approved October 12)

RALTEGRAVIR (approved October 12)

DEXRAZOXANE HYDROCHLORIDE (approved September 6)

LANREOTIDE ACETATE (approved August 30)

MARAVIROC (approved August 6)

AMBRISENTAN (approved June 15)

ARMODAFINIL (approved June 15)

TEMSIROLIMUS (approved May 30)

LEVOCETIRIZINE DIHYDROCHLORIDE (approved May 25)

ROTIGOTINE (approved May 9)

RETAPAMULIN (approved April 13)

PROTEIN C CONCENTRATE (HUMAN) (approved March 30)

ECULIZUMAB (approved March 16)

LAPATINIB DITOSYLATE (approved March 13)

ALISKIREN (approved March 5)

LISDEXAMFETAMINE DIMESYLATE (approved February 23)

2006 U.S. FDA Drug Approvals

PALIPERIDONE (approved December 19)

KUNECATECHINS (approved October 31)

TELBIVUDINE (approved October 25)

CICLESONIDE (approved October 20)

SITAGLIPTIN PHOSPHATE (approved October 17)

VORINOSTAT (approved October 6)

ARFORMOTEROL TARTRATE (approved October 6)

BISMUTH SUBCITRATE POTASSIUM/METRONIDAZOLE/TETRACYCLINE HYDROCHLORIDE (approved September 28)

PANITUMUMAB (approved September 27)

POSACONAZOLE (approved September 15)

IDURSULFASE (approved July 24)

RANIBIZUMAB (approved June 30)

DASATINIB (approved June 28)

DARUNAVIR (approved June 23)

HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE QUADRIVALENT (Types 6, 11, 16, 18) (approved June 8)

ZOSTER VACCINE LIVE (approved May 26)

RASAGILINE (approved May 17)

NABILONE (approved May 15)

VARENICLINE (approved May 10)

DECITABINE (approved May 2)

ALGLUCOSIDASE ALFA (approved April 28)

ANIDULAFUNGIN (approved February 21)

ROTAVIRUS VACCINE, LIVE, ORAL PENTAVALENT (approved February 3)

LUBIPROSTONE (approved January 31)

INSULIN HUMAN INHALED (approved January 27)

RANOLAZINE (approved January 27)

SUNITINIB (approved January 26)

2005 U.S. FDA Drug Approvals

CONIVAPTAN (approved December 30)

LENALIDOMIDE (approved December 27)

ABATACEPT (approved December 23)

SORAFENIB (approved December 20)

DEFERASIROX (approved November 2)

NELARABINE (approved October 28)

MECASERMIN (approved August 30)

NEPAFENAC (approved August 19)

RAMELTEON (approved July 22)

TIPRANAVIR (approved June 22)

INSULIN DETEMIR (approved June 16)

TIGECYCLINE (approved June 15)

EXENATIDE (approved April 28)

ENTECAVIR (approved March 29)

MICAFUNGIN (approved March 16)

PRAMLINTIDE (approved March 16)

2004 U.S. FDA Drug Approvals

PREGABALIN (approved December 30)

ILOPROST (approved December 29)

ZICONOTIDE (approved December 28)

CLOFARABINE (approved December 28)

DARIFENACIN HYDROBROMIDE (approved December 22)

PEGAPTANIB SODIUM (approved December 17)

TRYPAN BLUE (approved December 16)

PALIFERMIN (approved December 15)

ESZOPICLONE (approved December 15)

GADOBENATE DIMEGLUMINE (approved November 23)

NATALIZUMAB (approved November 23)

SOLIFENACIN SUCCINATE (approved November 19)

ERLOTINIB HYDROCHLORIDE (approved November 18)

OMEGA3-ACID ETHYL ESTERS (approved November 10)

LANTHANUM CARBONATE HYDRATE (approved October 26)

LUTROPIN ALFA (approved October 8)

PENTETATE CALCIUM TRISODIUM (approved August 11)

PENTETATE ZINC TRISODIUM (approved August 11)

DULOXETINE HYDRCHLORIDE (approved August 3)

EMTRICITABINE/TENOFOVIR (approved August 2)

ACAMPROSATE (approved July 29)

Ezetimibe/simvastatin (approved July 23)

TECHNETIUM 99M TC FANOLESOMAB (approved July 2)

LGLUTAMINE (approved June 10)

TROSPIUM CHLORIDE (approved May 28)

RIFAXIMIN (approved May 25)

AZACITIDINE (approved May 19)

TINIDAZOLE (approved May 17)

APOMORPHINE (approved April 20)

INSULIN GLULISINE (approved April 16)

TELITHROMYCIN (approved April 1)

CINACALCET HYDROCHLORIDE (approved March 8)

BEVACIZUMAB (approved February 26)

CETUXIMAB (approved February 12)

PEMETREXED DISODIUM (approved February 4)

TIOTROPIUM BROMIDE (approved January 30)

2003 U.S. FDA Drug Approvals

EPINASTINE (approved June 11)

PRUSSIAN BLUE (approved June 11)

EMTRICITABINE (approved August 2)

SERTACONAZOLE (approved December 16)

ABARELIX (approved November 25)

TADALAFIL (approved November 21)

EFALIZUMAB (approved October 27)

BOTULISM IMMUNE GLOBULIN INTRAVENOUS (approved October 23)

FOSAMPRENAVIR (approved October 20)

MEMANTINE (approved October 16)

DAPTOMYCIN (approved September 12)

VARDENAFIL (approved August 19)

ROSUVASTATIN (approved August 13)

MIGLUSTAT (approved July 31)

PALONOSETRON (approved July 25)

TOSITUMOMAB (approved June 30)

ATAZANAVIR (approved June 20)

OMALIZUMAB (approved June 20)

INFLUENZA VACCINE (INTRANASAL) (approved June 17)

ALFUZOSIN (approved June 12)

LARONIDASE (approved May 30)

IBANDRONATE (approved May 16)

BORTEZOMIB (approved May 13)

GEFITINIB (approved May 5)

AGALSIDASE BETA (approved April 24)

GEMIFLOXACIN (approved April 4)

APREPITANT (approved March 26)

PEGVISOMANT (approved March 25)

ENFUVIRTIDE (approved March 13)

ALEFACEPT (approved January 31)

2002 U.S. FDA Drug Approvals

GLIPIZIDE/METFORMIN (approved December 31)

ADALIMUMAB (approved December 31)

ELETRIPTAN (approved December 26)

ICODEXTRIN (approved December 20)

ATOMOXETINE (approved November 26)

NITAZOXANIDE (approved November 22)

ARIPIPRAZOLE (approved November 15)

ROSIGLITAZONE/METFORMIN (approved October 10)

EPLERENONE (approved September 27)

ADEFOVIR (approved September 20)

ESCITALOPRAM (approved August 14)

OXALIPLATIN (approved August 9)

TEGASEROD (approved July 24)

EZETIMIBE (approved July 23)

SODIUM OXYBATE (approved July 17)

RASBURICASE (approved July 12)

PERFLEXANE (approved May 31)

VORICONAZOLE (approved May 24)

TREPROSTINIL (approved May 21)

FULVESTRANT (approved April 25)

OLMESARTAN (approved April 15)

IBRITUMOMAB TIUXETAN (approved February 19)

PEGFILGRASTIM (approved January 31)

HYDROXYAMPHETAMINE/TROPICAMIDE (approved January 30)

NITISINONE (approved January 18)

2001 U.S. FDA Drug Approvals

DESLORATADINE (approved December 21)

PIMECROLIMUS (approved December 13)

FONDAPARINUX (approved December 7)

ERTAPENEM (approved November 29)

TENOFOVIR (approved November 29)

DROTRECOGIN ALFA (approved November 21)

DUTASTERIDE (approved November 20)

BOSENTAN (approved November 20)

VALDECOXIB (approved November 20)

ANAKINRA (approved November 14)

DEXMETHYLPHENIDATE (approved November 13)

FROVATRIPTAN (approved November 12)

DARBEPOETIN ALFA (approved September 18)

CEFDITOREN (approved August 29)

ZOLEDRONATE (approved August 20)

PERFLUTREN (approved July 31)

NESIRITIDE (approved July 13)

IMATINIB (approved May 10)

ALEMTUZUMAB (approved May 7)

ALMOTRIPTAN (approved May 7)

VALGANCICLOVIR (approved March 29)

TRAVOPROST (approved March 16)

BIMATOPROST (approved March 16)

GALANTAMINE (approved February 28)

ESOMEPRAZOLE (approved February 20)

FORMOTEROL (approved February 16)

ZIPRASIDONE (approved February 5)

CASPOFUNGIN (approved January 29)

PEGINTERFERON ALFA-2B (approved January 19)

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