About FDA
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Licensed Products (BLA)
as of 10/13/10
| BLA Number | Proprietary Name | USAN Name |
|---|---|---|
| 101063 | Elspar | asparaginase |
| 101995 | Santyl | collagenase |
| 103000 | Botox | onabotulinumtoxin A |
| 103132 | Intron A | interferon alfa -2B |
| 103145 | Roferon -A | interferon alfa -2A |
| 103158 | Alferon | interferon alfa - N3 |
| 103172 | Activase | alteplase, tPA, cathflow |
| 103234 | Epogen | epoetin alfa |
| 103293 | Proleukin | aldesleukin |
| 103353 | Neupogen | filgrastim |
| 103362 | Leukine | sargramostim |
| 103411 | Oncaspar | pegaspargase |
| 103463 | Orthoclone OKT3 | muromonab-CD3 |
| 103471 | Betaseron | interferon beta -1B |
| 103532 | Pulmozyme | dormase alfa |
| 103575 | Reopro | abciximab |
| 103608 | Prostascint | capromab pendetide |
| 103628 | Avonex | interferon beta -1A |
| 103663 | Infergen | interferon alfacon-1 |
| 103691 | Regranex | becaplermin |
| 103692 | Regranex | becaplermin concentrated |
| 103694 | Neumega | oprelvekin |
| 103705 | Rituxan | rituximab |
| 103749 | Zenapax | daclizumab |
| 103764 | Simulect | basiliximab |
| 103767 | Ontak | denileukin diftitox |
| 103769 | Verluma | nofetumomab |
| 103770 | Synagis | palivizumab |
| 103772 | Remicade | infliximab |
| 103780 | Rebif | interferonbeta -1a |
| 103786 | Retavase | reteplase |
| 103792 | Herceptin | trastuzumab |
| 103795 | Enbrel | etanercept |
| 103836 | Actimmune | interferon gamma - 1B |
| 103846 | Myobloc | rimabotulinumtoxin B |
| 103909 | TNKase | tenecteplase |
| 103928 | Neutrospec | fanolesomab |
| 103946 | Elitek | rasburicase |
| 103948 | Campath | alemtuzumab |
| 103949 | Pegintron | peginterferon alfa - 2B |
| 103950 | Kineret | anakinra |
| 103951 | Aranesp | darbepoetin alfa |
| 103964 | Pegasys | peginterferon alfa - 2A |
| 103976 | Xolair | omalizumab |
| 103979 | Fabrazyme | agalsidase beta |
| 125011 | Bexxar | tositumomab |
| 125019 | Zevalin | ibritumomab tiuxetan |
| 125029 | Xigris | drotrecogin alfa (activated) |
| 125031 | Neulasta | pegfilgrastim |
| 125036 | Amevive | alefacept |
| 125057 | Humira | adalimumab |
| 125058 | Aldurazyme | laronidase |
| 125075 | Raptiva | efalizumab |
| 125083 | Pegasys Copegus | Peginterferon alfa-2a co-packaged with Ribavirin |
| 125084 | Erbitux | cetuximab |
| 125085 | Avastin | bevacizumab |
| 125103 | Kepivance | palifermin |
| 125104 | Tysabri | natalizumab |
| 125117 | Naglazyme | galsulfase |
| 125118 | Orencia | abatacept |
| 125141 | Myozyme | alpha-glucosidase |
| 125147 | Vectibix | panitumumab |
| 125151 | Elaprase | idursulfase |
| 125156 | Lucentis | ranibizumab |
| 125160 | Cimzia | certolizumab pegol |
| 125164 | Mircera | methoxy polyethylene glycol-epoetin beta |
| 125166 | Soliris | eculizumab |
| 125196 | PegPak | Peginterferon alfa-2b co-packaged with Ribavirin |
| 125249 | Arcalyst | rilonacept |
| 125261 | Stelara | ustekinumab |
| 125268 | Nplate | romiplostim |
| 125274 | Dysport | abobotulinumtoxin A |
| 125276 | Actemra | tocilizumab |
| 125277 | Kalbitor | ecallantide |
| 125289 | Simponi | golimumab |
| 125290 | Extavia | INF beta-1b |
| 125291 | Lumizyme | algucosidase alfa |
| 125319 | Illaris | canakinumab |
| 125326 | Arzerra | ofatumumab |
| 125338 | Xiaflex | clostridial collagenase |
| 125360 | Xeomin | incobotulinumtoxin A |
as of 10/13/10
| NDA Number | Proprietary Name | USAN Name |
|---|---|---|
| 6343 | Wydase | hyaluronidase |
| 11903 | Zolyse | chymotrypsin |
| 12828 | Travase Ointment | sutilains |
| 18663 | Chymodiactin | chymopapain |
| 19818 | Adagen | pegademase |
| 19841 | Indium in 111 chloride | Indium in 111 chloride |
| 19862 | Indiclor | Indium in 111 chloride |
| 20057 | Ceredase | alglucerase |
| 20304 | Trasylol | aprotinin |
| 20367 | Cerezyme | imiglucerase |
| 20580 | Cotazym | pancrelipase |
| 20725 | Creon | pancrelipase |
| 20772 | Sucraid | sacrosidase |
| 21640 | Vitrase | hyaluronidase |
| 21665 | Amphadase | hyaluronidase |
| 21716 | Hydase | hyaluronidase |
| 21846 | Kinlytic | urokinase |
| 21859 | Hylenex | hyaluronidase |
| 22210 | Zenpep | pancrelipase |
| 22523 | Pancreaze | pancrelipase |
| 22575 | VPRIV | velaglucerase alfa |
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