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YearBrandBLA/ NDADrugs@FDA LinkDrug Trial Snapshot LinkEnrollment (per Snapshot)Number of Clinical Trials (per Snapshot)Clinical Trial NCT # (per Snapshot)INNFDA Approval dateDate of EMA approval (D/M/Y form)FDA Review ClassORIGNDA Chem TypeWHO ATC CodeOrphan for initial approved indicationNumber of Orphan indications approved on date of initial FDA approvalDesignation Date for initial orphan indicationFDA numberBreakthrough* (Designation began 2013)FastrackPRVIndicationShort indicationCancerOriginal applicantCompanyOriginal label URL
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1998CelebrexNDAcelecoxib1998-Dec-31PriorityType 120998GD SEARLE
3
1998ProvigilNDAmodafinil1998-Dec-24StandardType 120717CEPHALON
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1998ZiagenNDAabacavir sulfate1998-Dec-17PriorityType 120977VIIV HLTHCARE
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1998ThyrogenBLAthyrotropin alfa1998-Nov-3020898GENZYME
6
1998MicardisNDAtelmisartan1998-Nov-10StandardType 120850BOEHRINGER INGELHEIM
7
1998EnbrelBLAetanercept1998-Nov-02103795IMMUNEX
8
1998RenagelNDAsevelamer hydrochloride1998-Oct-30StandardType 120926GENZYME
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1998
Valstar Preservative Free
NDAvalrubicin1998-Sep-25PriorityType 120892ENDO PHARM
10
1998HerceptinBLAtrastuzumab1998-Sep-25103792GENENTECH
11
1998SustivaNDAefavirenz1998-Sep-17PriorityType 120972BRISTOL MYERS SQUIBB
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1998AcutectNDAtechnetium tc-99m apcitide1998-Sep-14PriorityType 120887CIS BIO INTL SA
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1998AravaNDAleflunomide1998-Sep-10PriorityType 120905SANOFI AVENTIS US
14
1998
Vitravene Preservative Free
NDAfomivirsen sodium1998-Aug-26PriorityType 120961NOVARTIS
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1998RemicadeBLAinfliximab1998-Aug-24103772CENTOCOR INC
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1998CelexaNDAcitalopram hydrobromide1998-Jul-17StandardType 120822ALLERGAN
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1998ThalomidNDAthalidomide1998-Jul-16PriorityType 120785CELGENE
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1998
Infasurf Preservative Free
BLAcalfactant1998-Jul-0120521ONY
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1998MaxaltNDArizatriptan benzoate1998-Jun-29StandardType 120864MERCK
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1998PriftinNDArifapentine1998-Jun-22PriorityType 121024SANOFI AVENTIS US
21
1998SynagisBLApalivizumab1998-Jun-19103770MEDIMMUNE
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1998AtacandNDAcandesartan cilexetil1998-Jun-04StandardType 120838ANI PHARMS INC
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1998IntegrilinNDAeptifibatide1998-May-18PriorityType 120718SCHERING
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1998AggrastatNDAtirofiban hydrochloride1998-May-14PriorityType 120912MEDICURE
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1998SimulectBLAbasiliximab1998-May-12103764NOVARTIS
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1998RetavaseBLAreteplase1998-May-06103786EKR THERAP
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1998XelodaNDAcapecitabine1998-Apr-30PriorityType 120896HOFFMANN LA ROCHE
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1998ZemplarNDAparicalcitol1998-Apr-17StandardType 120819ABBVIE
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1998SucraidBLAsacrosidase1998-Apr-0920772QOL MEDCL
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1998AzoptNDAbrinzolamide1998-Apr-01StandardType 120816NOVARTIS
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1998ActonelNDArisedronate sodium1998-Mar-27StandardType 120835APIL
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1998ViagraNDAsildenafil citrate1998-Mar-27PriorityType 120895UPJOHN
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1998DetrolNDAtolterodine tartrate1998-Mar-25StandardType 120771UPJOHN
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1998AlrexNDAloteprednol etabonate1998-Mar-09StandardType 120803BAUSCH AND LOMB
35
1998LotemaxNDAloteprednol etabonate1998-Mar-09StandardType 120583BAUSCH AND LOMB
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1998SingulairNDAmontelukast sodium1998-Feb-20StandardType 120829MSD MERCK CO
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1998AmergeNDAnaratriptan hydrochloride1998-Feb-10StandardType 120763GLAXOSMITHKLINE LLC
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1998TasmarNDAtolcapone1998-Jan-29StandardType 120697BAUSCH
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1999TargretinNDABexarotene1999-Dec-29PRIORITYORIG-1Type 1ORPHAN06/18/199921055N/A
Targretin is indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy
Cutaneous T-cell lymphoma
CancerLigand PharmVALEANT LUXEMBOURG
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21055lbl.pdf
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1999INOmaxNDANitric Oxide1999-Dec-23PRIORITYORIG-1Type 1ORPHAN06/22/199320845N/A
INOmax is indicated an an conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence or pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation
Hypoxic Respiratory Failure, Pulmonary Hypertension
INO TherapeuticsMALLINCKRODT HOSP
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20845lbl.htm
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1999PrecedexNDADexmedetomidine Hydrochloride1999-Dec-17STANDARDORIG-1Type 121038N/A
Precedex is indicated for the sedation of initially intubated and mechanically ventilated adult patients in an ICU setting
SedationAbbott LabsHOSPIRA
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21038lbl.pdf
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1999TequinNDAGatifloxacin1999-Dec-17STANDARD21061N/A
Tequin is indicated for the treatment of acute bacterial sinusitis, community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, urinary tract infections, pyelonephritis, and uncomplicated gonorrhea
Infections (Sinusitis, Bronchitis, Pneumonia, Urinary...)
Bristol-Myers Squibb
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1999SolageNDAMequinol; Tretinoin1999-Dec-10STANDARDORIG-1Type 120922N/A
Solage is indicated for the treatment of solar lentigines
Solar LentiginesBristol-Myers SquibbAQUA PHARMS
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20922lbl.pdf
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1999AveloxNDAMoxifloxacin Hydrochloride1999-Dec-10STANDARDORIG-1Type 121085N/A
Avelox is indicated for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia
Infections (Sinusitis, Bronchitis, Pneumonia)
BayerBAYER HLTHCARE
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21085lbl.pdf
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1999OptimarkNDAGadoversetamide1999-Dec-08STANDARDORIG-1Type 120937N/A
Optimark is indicated for the use with magnetic resonance imaging (MRI) in patients with an abnormal blood barrier or abnormal vascularity of the brain, spine and associated tissues; and with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities identified on computerized tomography
MRIMallinckrodtLIEBEL-FLARSHEIM
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf
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1999
Levulan Kerastick
NDAAminolevulinic Acid Hydrochloride1999-Dec-03STANDARDORIG-1Type 120965N/A
Levulan Kerastick plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of non-hyperkeratotic actinic keratoses of the face and scalp
Non-hyperkeratotic Actinic Keratoses
DUSA PharmDUSA
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20965lbl.pdf
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1999KeppraNDALevetiracetam1999-Nov-30STANDARDORIG-1Type 121035N/A
Keppra is indicated as an adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy
EpilepsyUCB PharmUCB INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21035lbl.pdf
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1999CurosurfNDAPoractant Alfa1999-Nov-18STANDARDORIG-1Type 1ORPHAN08/02/199320744N/A
Curosurf is indicated for the treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants
Respiratory Distress Syndrome
Dey LabsCHIESI USA INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20744lbl.pdf
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1999TamifluNDAOseltamivir Phosphate1999-Oct-27PRIORITYORIG-1Type 121087N/A
Tamiflu is indicated as a treatment of influenza A and B
Influenza A and BHoffman-La RocheROCHE
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21087lbl.pdf
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1999AromasinNDAExemestane1999-Oct-21STANDARDORIG-1Type 1ORPHAN09/19/199120753N/A
Aromasin is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy
Breast Cancer CancerPharmacia & UpjohnPHARMACIA AND UPJOHN
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20753LBL.PDF
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1999ComtanNDAEntacapone1999-Oct-19STANDARDORIG-1Type 120796N/A
Comtan is indicated as an adjunct to levodopa/carbidopa to treat patients with idiopathic Parkinson’s Disease who experience the signs and symptoms of end-of-dose "wearing-off" (so called "fluctuating" patients)
Idiopathic Parkinson’s Disease
OrionORION PHARMA
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20796LBL.PDF
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1999TikosynNDA Dofetilide1999-Oct-01STANDARDORIG-1Type 120931N/A
Tikosyn is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm
Conversion of Atrial Fibrillation and Atrial Flutter to Normal Sinus Rhythm
PfizerPFIZER
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20931lbl.pdf
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1999AlamastNDAPemirolast Potassium1999-Sep-24PRIORITYORIG-1Type 121079N/A
Alamast is indicated for the prevention of itching of the eye due to allergic conjunctivitis
Allergic ConjunctivitisSantenSANTEN
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21079lbl.pdf
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1999Synercid IVNDAQuinupristin; Dalfopristin1999-Sep-21PRIORITYORIG-1Type 150747N/A
Synercid is indicated for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia
Vancomycin-resistant Enterococcus faecium (VREF) bacteremia
Rhone Poulenc RorerKING PHARMS
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50747lbl.pdf
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1999RapamuneNDASirolimus1999-Sep-15PRIORITYORIG-1Type 121083N/A
Rapamune is indicated for prophylaxis of organ rejection in patients receiving renal transplants
Prophylaxis of Organ Rejection
WYeth-AyerstPF PRISM CV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21083A_Rapamune_appltr.pdf
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1999EllenceNDA Epirubicin Hydrochloride1999-Sep-15PRIORITYORIG-1Type 1ORPHAN09/14/199950778N/A
Ellence is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer
Breast Cancer CancerPharmacia & UpjohnPFIZER INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50778lbl.pdf
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1999 AciphexNDARabeprazole Sodium1999-Aug-19STANDARDORIG-1Type 120973N/A
Aciphex is indicated for 1) healing of erosive or ulcerative gastroesophageal reflux disease (GERD); 2) maintenance of healing of erosive or ulcerative GERD; 3) healing of duodenal ulcer; 4) treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome
Gastroesophageal Reflux Disease, Ulcers, Zollinger-Ellison Syndrome
Eisai (US)EISAI INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20973lbl.pdf
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1999 RaplonNDA Rapacuronium Bromide1999-Aug-18STANDARDORIG-1Type 120984N/A
Raplon is indicated for outpatients and inpatients as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgical procedures
AnesthesiaOrganonORGANON USA INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20984lbl.pdf
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1999SonataNDA Zaleplon1999-Aug-13STANDARDORIG-1Type 120859N/A
Sonata is indicated for the short-term treatment of insomnia
InsomniaWyeth-AyerstPFIZER
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20859lbl.pdf
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1999TemodarNDATemozolomide1999-Aug-11PRIORITYORIG-1Type 1ORPHAN10/05/199821029N/A
Temodar is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine
Refractory Anaplastic Astrocytoma
CancerScheringMERCK SHARP DOHME
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21029lbl.pdf
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1999NeoTectNDATechnetium Tc-99m Depreotide Kit1999-Aug-03PRIORITYORIG-1Type 121012N/A
Technetium Tc-99m Depreotide is indicated for patients presenting with pulmonary lesions on computed tomography and/or chest x-ray who have known malignancy or who are highly suspect for malignancy
Diagnostic Test for Pulmonary Lesions
DiatideCIS BIO INTL SA
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21012lbl.pdf
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1999AntagonNDA Ganirelix Acetate1999-Jul-29PRIORITYORIG-1Type 121057N/A
Antagon is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation
Prevent Premature Luteinizing Hormone
OrganonORGANON USA INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21057lbl.pdf
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1999RelenzaNDAZanamivir1999-Jul-26PRIORITYORIG-1Type 121036N/A
Relenza is indicated for the treatment of uncomplicated acute illness due to influenza virus in adults and adolescents twelve years and older who have been symptomatic for no more than two days
Influenza VirusGlaxo WellcomeGLAXOSMITHKLINE
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21036lbl.pdf
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1999ActosNDAPioglitazone Hydrochloride1999-Jul-15PRIORITYORIG-1Type 121073N/A
Actos is indicated for the improvement of glycemic control in patients with type 2 diabetes as monotherapy, or in combination with a sulfonylurea, metformin or insulin when diet and the single agent does not result in adequate glycemic control
Type 2 DiabetesTakeda AmericaTAKEDA PHARMS USA
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf
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1999ZaditorNDAKetotifen Fumarate1999-Jul-02PRIORITYORIG-1Type 121066N/A
Zaditor is indicated for the prevention of itching of the eye due to allergic conjunctivitis
Allergic ConjunctivitisCiba VisionALCON PHARMA
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21066lbl.pdf
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1999HectorolNDADoxercalciferol1999-Jun-09STANDARDORIG-1Type 120862N/A
Hectorol is indicated for the reduction of elevated iPTH levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis
HyperparathyroidismBone Care International GENZYME CORP
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20862lbl.pdf
67
1999AvandiaNDARosiglitazone Maleate1999-May-25PRIORITYORIG-1Type 121071N/A
Avandia is indicated for the treatment of type 2 diabetes mellitus as monotherapy or in combination with metformin
Type 2 DiabetesSmithKline BeechamSB PHARMCO
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21071lbl.pdf
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1999VioxxNDA Rofecoxib1999-May-20PRIORITYORIG-1Type 121042N/A
Vioxx is indicated for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain and for the treatment of primary dysmenorrhea
Osteoarthritis, Pain, Dysmenorrhea
MerckMERCK
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21042lbl.pdf
69
1999XenicalNDA Orlistat1999-Apr-23PRIORITYORIG-1Type 120766N/A
Xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. Xenical is also indicated to reduce the risk for weight re-gain after prior loss
ObesityHoffman-La RocheCHEPLAPHARM
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf
70
1999AgeneraseNDAAmprenavir1999-Apr-15PRIORITYORIG-1Type 121007N/AYes
Agenerase is a protease inhibitor that is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection
HIVGlaxo WellcomeGLAXOSMITHKLINE
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21007lbl.pdf
71
1999FerrlecitNDASodium Ferric Gluconate Complex1999-Feb-18PRIORITYORIG-1Type 120955N/A
Ferrlicit is indicated for the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy
Iron Deficiency AnemiaR&D LabSANOFI AVENTIS US
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20955lbl.pdf
72
1999PanretinNDAAlitretinoin1999-Feb-02PRIORITYORIG-1Type 1ORPHAN03/24/199820886N/A
Panretin is indicated for the treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma
Cutaneous Lesions caused by Kaposi Sarcoma
Ligand PharmEISAI INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20886lbl.pdf
73
1999PletalNDACilostazol1999-Jan-15STANDARDORIG-1Type 120863N/A
Pletal is indicated for the treatment of intermittent claudication
Intermittent ClaudicationOtsuka PharmOTSUKANo Label
74
2000StarlixNDANateglinide2000-Dec-22STANDARDORIG-1Type 121204N/A
Provides for the use of Starlix as monotherapy, as an adjunct to diet and exercise to improve gylcemic control in patients with type 2 diabetes. In addition, it provides for the use of Starlix concomitantly with metformin to improve glycemic control
Type 2 Diabetes Novartis PharmsNOVARTIS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21204lbl.pdf
75
2000AngiomaxNDABivalirudin2000-Dec-15STANDARDORIG-1Type 120873N/A
Angiomax is used as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA)
Antiocoagulant for Unstable Angina
The Medicines CompanyTHE MEDICINES CO
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf
76
2000MifeprexNDAMifepristone2000-Sep-28PRIORITYORIG-1Type 120687N/A
Mifeprex is indicated for medical termination of intrauterine pregnancy through 49 days’ pregnancy
Intrauterine Pregnancy Termination
Population CouncilDANCO LABS LLC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.pdf
77
2000TrisenoxNDAArsenic Trioxide2000-Sep-25PRIORITYORIG-1Type 1ORPHAN103/03/199821248N/AYes
Trisenox is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
Acute Promyelocytic Leukemia
CancerCell TherapeuticsCEPHALON
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21248lbl.pdf
78
2000KaletraNDALopinavir; Ritonavir2000-Sep-15PRIORITYORIG-1Type 121226N/AYes
Keletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infections in adults and pediatric patients age six months and older
HIVAbbott LabsABBVIE
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21226lbl.pdf
79
2000CetrotideNDACetrorelix Acetate2000-Aug-11STANDARDORIG-1Type 121197N/A
Cetrotide is indicated for the prevention of premature LH surges in women undergoing controlled ovarian stimulation
Prevent Premature Luteinizing Hormone
SeronoEMD SERONO INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf
80
2000ResculaNDAUnoprostone Isopropyl2000-Aug-03PRIORITYORIG-1Type 121214N/A
Rescula is indicated for the lowering of intraocular pressure in patients with open-angel glaucoma or ocular hypertension who are intolerant of other intraocular pressure lowering medications or insufficiently responsive (failed to achieve target IOP determined after multiple measurements over time) to another intraocular pressure lowering medication
Open-angle Glaucoma or Ocular Hypertension
Ciba VisionSUCAMPO PHARMA LLC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21214lbl.pdf
81
2000AbrevaNDADocosanol2000-Jul-25STANDARDORIG-1Type 120941N/A
Abreva is indicated for the treatment of cold sores and fever blisters
Cold Sores and Fever Blisters
SKB Cons HealthcareGLAXOSMITHKLINE
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20941lbl.pdf
82
2000ColazalNDABalsalazide Disodium2000-Jul-18STANDARDORIG-1Type 120610N/A
Colazal is indicated for the treatment of mildly to moderate active ulcerative colitis
Ulcerative ColitisSalix PharmVALEANT PHARMS INTL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20610lbl.pdf
83
2000InnohepNDATinzaparin Sodium2000-Jul-14STANDARDORIG-1Type 120484N/A
Innohep is indicated for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium
Deep Vein ThrombosisDupont LEO PHARMA AS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20484lbl.pdf
84
2000AcovaNDAArgatroban2000-Jun-30STANDARDORIG-1Type 120883N/A
Acova is indicated as an anticoagulant for prophylaxis or treatment of thrombosis patients with heparin-induced thrombocytopenia
ThrombosisTexas BiotechNOVARTIS PHARMS CORP
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20883lbl.pdf
85
2000Trelstar DepotNDATriptorelin Pamoate2000-Jun-15STANDARDORIG-1Type 120715N/A
Trelstar Depot is indicated for the palliative treatment of advanced prostate cancer
Prostate CancerCancerDebio RechercheALLERGAN SALES LLC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20715lbl.pdf
86
2000NovoLogNDAInsulin Aspart Recombinant2000-Jun-07STANDARDORIG-1Type 120986N/A
NovoLog is indicated for the treatment of adult patients with diabetes mellitus, for the control of hyperglycemia
Diabetes MellitusNovo NordiskNOVO NORDISK INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20986lbl.pdf
87
2000WelcholNDAColesevelam Hydrochloride2000-May-26STANDARDORIG-1Type 121176N/A
Welchol is indicated for the reduction of elevated LDL-cholesterol, alone or in combination with an HMG-CoA reductase inhibitor, in patients with primary hypercholesterolemia (Frederickson Type IIa)
HypercholesterolemiaSankyo PharmDAIICHI SANKYO
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_prntlbl.pdf
88
2000MylotargNDAGemtuzumab Ozogamicin2000-May-17PRIORITYORIG-1Type 1ORPHAN111/24/199921174N/A
Mylotarg is indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy
Acute Myeloid Leukemia
CancerWyeth-AyerstWYETH PHARMS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21174lbl.pdf
89
2000ExelonNDARivastigmine Tartrate2000-Apr-21STANDARDORIG-1Type 120823N/A
Exelon is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type
Dementia, Alzheimer's Disease
Novartis PharmsNOVARTIS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20823lbl.pdf
90
2000LantusNDAInsulin Glargine2000-Apr-20STANDARDORIG-1Type 121081N/A
Lantus is indicated for once-daily subcutaneous administration at bedtime in the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia
Type 1 and Type 2 Diabetes
Aventis PharmsSANOFI AVENTIS US
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21081lbl.pdf
91
2000ZyvoxNDALinezolid2000-Apr-18PRIORITYORIG-1Type 121130N/A
Zyvox is indicated for the treatment of adult patients with vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, complicated and uncomplicated skin and skin structure infections, and community-acquired pneumonia
Infections (Skin, Pneumonia, Enterococcus faecium infections)
Pharmacia & UpjohnPHARMACIA AND UPJOHN
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf
92
2000MobicNDAMeloxicam2000-Apr-13STANDARDORIG-1Type 120938N/A
Mobic is indicated for the relief of the signs and symptoms of osteoarthritis
OsteoarthritisBoehringer Ingleheim PharmsBOEHRINGER INGELHEIM
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20938lbl.pdf
93
2000VisudyneNDAVerteporfin2000-Apr-12PRIORITYORIG-1Type 121119N/A
Visudyne provides for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization
Macular DegenerationQLT PhotoVALEANT LUXEMBOURG
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21119lbl.pdf
94
2000SeptocaineNDAArticaine Hydrochloride, Epinephrine2000-Apr-03STANDARDORIG-1Type 120971N/A
Septocaine is indicated for infiltration or nerve block anesthesia for dentistry
Infiltration or Nerve Block Anesthesia
DeprocoDEPROCO
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-971_Septocaine_prntlbl.pdf
95
2000ZonegranNDAZonisamide2000-Mar-27STANDARDORIG-1Type 120789N/A
Zonegran is used as an adjunctive therapy in the treatment of partial seizures in adults with epilepsy
EpilepsyDainippon PharmSUNOVION PHARMS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20789lbl.pdf
96
2000
Skin Exposure Reduction Paste Against Chemical Warfare Agents
NDA
Perfluoro-polymethyl-isopropyl Ether; Polytetrafluoro-ethylene
2000-Feb-17PRIORITYORIG-1Type 121084N/A
Provides for the use of SERPACWA only in conjunction with Mission Oriented Protective Posture (MOPP) gear to reduce or delay the absorption of chemical warfare agents through the skin when SERPACWA is applied prior to exposure
SERPACWA; Skin Exposure
U.S. ArmyUS ARMY
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21084lbl.pdf
97
2000LotronexNDAAlosetron Hydrochloride2000-Feb-09PRIORITYORIG-1Type 121107N/A
Lotronex is indicated for the treatment of irritable bowel syndrome (IBS) in female patients whose predominant bowel symptom is diarrhea
Irritable Bowel Syndrome
Glaxo WellcomeSEBELA IRELAND LTD
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21107lbl.pdf
98
2000ProtonixNDAPantoprazole Sodium2000-Feb-02STANDARDORIG-1Type 120987N/A
Protonix is indicated for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD)
Esophagitis, Gastroesophageal Reflux Disease
Wyeth-AyerstWYETH PHARMS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20987lbl.pdf
99
2000TrileptalNDAOxcarbazepine2000-Jan-14STANDARDORIG-1Type 121014N/A
Trileptal is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults with epilepsy and as adjunctive therapy in the treatment of partial seizures in children ages 4-16 with epilepsy
EpilepsyNovartis PharmsNOVARTIS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21014lbl.pdf
100
2000EvoxacNDACevimeline Hydrochloride2000-Jan-11STANDARDORIG-1Type 120989N/A
Evoxac is indicated for the treatment of symptoms of dry mouth in patients with Sjogren’s Syndrome
Sjogren’s SyndromeShowBrandDAIICHI SANKYO INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20989lbl.pdf