Table 2.--Comparative Studies Non-Blinded Trials ; Evaluating Pamidronate for the Treatment of Hypercalcemia of Malignancy Total No. of Patients Non-blinded Trials 39 Response Evaluation Serum calcium level at day 9 a ; vs .05 * a ; vs c ; .05. Blaf ml bla number proprietary name proper name applicant rc approval date bl125141 myozyme alglucosidase alfa genzyme p, o 28-apr-2006 bl125156 lucentis ranibizumab genentech p 30-jun-2006 bl125151 elaprase idursulfase shire human genetic therapies p, o 24-jul-2006 bl125147 vectibix panitumumab amgen p 27-sep-2006 drugs and biologic approvals for calendar year 2005 ml nda number drug name generic name applicant sponsor ct rc approval date 1208 n021660 abraxane paclitaxel protein-bound particles american bioscience 5 s 07-jan-05 n021726 niravam alprazolam schwarz pharma 5 s 19-jan-05 z n021841 lamivudine; zidovudine; nevirapine lamivudine; zidovudine; nevirapine pharmacare 4 p 24-jan-05 * n021642 nascobal cyanocobalamin nastech pharma 3 s 31-jan-05 n021759 eloxatin oxaliplatin sanofi-synthelabo 5 s 31-jan-05 n021758 vanos fluocinonide medicis pharma 3 s 11-feb-05 n020645 ammonul sodium benzoate; sodium phenylacetate ucyclyd pharma 5 p, o 17-feb-05 n021269 cardura xl doxazosin mesylate pfizer 3 s 22-feb-05 n021764 brimonidine tartrate brimonidine tartrate alcon 3 s 28-feb-05 * n021605 clarinex d24 desloratadine; pseudoephedrine sulfate schering 3 s 03-mar-05 n021730 xopenex hfa levalbuterol tartrate sepracor 3 s 11-mar-05 n021332 symlin pramlintide acetate amylin 1 s 16-mar-05 1211 n021506 mycamine micafungin sodium fujisawa 1 p 16-mar-05 n021664 xibrom bromfenac sodium ista pharms 3 s 24-mar-05 n021584 depo-subq provera 104 medroxyprogesterone acetate pfizer 5 s 25-mar-05 1210 n021797 baraclude entecavir bristol myers squibb 1 p 29-mar-05 1210 n021798 baraclude entecavir bristol myers squibb 3 p 29-mar-05 n021067 asmanex twisthaler mometasone furoate schering 3 s 30-mar-05 n021152 cutivate fluticasone propionate glaxosmithkline 3 s 31-mar-05 n021689 nexium iv esomeprazole sodium astrazeneca 3 s 31-mar-05 z n021762 fosamax plus d alendronate sodium; vitamin d3 merck 4 s 07-apr-05 n021737 retisert fluocinolone acetonide bausch and lomb 3 p, o 08-apr-05 n021627 namenda memantine hydrochloride forest labs 3 s 18-apr-05 n050796 ceftriaxone sodium; dextrose in duplex container ceftriaxone sodium; dextrose b braun 5 s 20-apr-05 n021669 chlorhexidine gluconate cloth chlorhexidine gluconate sage prods 3 s 25-apr-05 1210 n021773 byetta exenatide amylin 1 s 28-apr-05 n021693 tramadol hydrochloride tramadol hydrochloride biovail labs 3 s 05-may-05 n050795 doryx doxycyclin hyclate faulding pharms 3 s 06-may-05 n021350 triglide fenofibrate skye pharma 3 s 07-may-05 n021744 proquin xr ciprofloxacin hydrochloride depomed 2 s 19-may-05 n021806 metronidazole metronidazole teva pharms 5 s 20-may-05 n021412 zolpidem tartrate zolpidem tartrate biovail labs 3 s 26-may-05 * n021606 zemplar paricalcitol abbott labs 3 s 26-may-05 n021802 focalin xr dexmethylphenidate hydrochloride novartis pharms 3 s 26-may-05 z n021524 chlorascrub chlorhexidine gluconate; isopropyl alcohol nice-pak 3 s 03-jun-05 n021748 glumetza metformin hydrochloride biovail labs 5 s 03-jun-05 n021845 revatio sildenafil citrate pfizer 5 p 03-jun-05 n021793 metoclopramide metoclopramide schwarz pharma 3 s 10-jun-05 n050797 zmax azithromycin pfizer 3 s 10-jun-05 n021821 tygacil tigecycline wyeth pharms 1 p 15-jun-05 n021536 levemir insulin detemir novo nordisk 1 s 16-jun-05 n021814 aptivus tipranavir boehringer ingelheim 1 p 22-jun-05 z n020727 bidil hydralazine hydrochloride; isosorbide dinitrate nitromed 4 s 23-jun-05 z n021623 synera lidocaine; tetracaine zars 4 s 23-jun-05 n021789 metrogel metronidazole dow pharm 3 s 30-jun-05 n021832 levofloxacin levofloxacin sicor pharms 3 s 30-jun-05 * n021778 megace es megestrol acetate par pharm 5 s 05-jul-05 n021794 aczone dapsone qlt usa 3 s 07-jul-05 n021782 rozerem ramelteon takeda global 1 s 22-jul-05 n021855 loperamide hydrochloride loperamide hydrochloride banner pharmacaps 3 s 4-aug-05 z n021823 actonel with calcium risedronate sodium; calcium carbonate proctor and gamble 4 s 12-aug-05 n021799 quinine sulfate quinine sulfate mutual 5 s 12-aug-05 n021406 fortical calcitonin-salmon rdna origin ; unigene 3 s 12-aug-05 n021862 nevanac nepafenac alcon 1 p 19-aug-05 n021770 alphagan p brimonidine tartrate allergan 3 s 19-aug-05 n021273 follistim aq follitropin beta organon 3 s 26-aug-05 z n021842 actoplus met metformin hydrochloride; pioglitazone hydrochloride takeda 4 s 29-aug-05 n021839 increlex mecasermin rdna origin ; tercica 1 p, o 30-aug-05 n021774 ambien cr zolpidem tartrate sanofi synthelabo 3 s 02-sep-05 n021692 tramadol hydrochloride tramadol hydrochloride biovail 5 s 08-sep-05 n021355 angeliq drospirenone; 17b-estradiol berlex 4 s 28-sep-05 n021896 emtriva emtricitabine gilead 3 p 28-sep-05 n021734 loratadine loratadine taro pharm 3 s 04-oct-05 n021716 hydase hyaluronidase primapharm 1 p 25-oct-05 n021835 clobex clobetasol propionate dow pharm 3 s 27-oct-05 n021877 arranon nelarabine glaxosmithkline 1 p, o 28-oct-05 n021906 kaletra lopinavir; ritonavir abbott labs 3 p 28-oct-05 n021807 soltamox tamoxifen citrate savient pharms 3 s 29-oct-05 n021882 exjade deferasirox novartis 1 p, o 02-nov-05 n021700 avandaryl rosiglitazone maleate; glimepride sb pharmco 4 s 23-nov-05 n021859 hylenex recombinant hyaluronidase human halozyme 1 p 02-dec-05 n021884 iplex mecasermin rinfabate insmed 1, 4 p, o 12-dec-05 n021763 citalopram hydrobromide citalopram hydrobromide biovail 3 s 20-dec-05 n021923 nexavar sorafenib tosylate bayer 1 p, o 20-dec-05 n021393 advil liqui-gels ibuprofen; diphenhydramine citrate wyeth 4 s 21-dec-05 n021394 advil caplets ibuprofen; diphenhydramine citrate wyeth 4 s 21-dec-05 n021880 revlimid lenalidomide celgene 1 p, o 27-dec-05 n021697 vaprisol conivaptan hydrochloride astellas 1 s 29-dec-05 blaf ml bla number proprietary name proper name applicant rc approval date bl125117 naglazyme galsulfase biomarin pharmaceutical inc p, o 31-may-05 1229 bl125118 orencia abatacept bristol-myers squibb p 23-dec-05 drugs and biologic approvals for calendar year 2004 ml nda number drug name generic name applicant sponsor ct rc approval date n021604 children's elixsure ib ibuprofen taro pharms 5 s 07-jan-04 n021539 acetadote acetylcysteine cumberland pharms 3 p, o 23-jan-04 n021646 infuvite pediatric multiple vitamins sabex 2002 5 s 29-jan-04 1183 n021395 spiriva handihaler tiotropium bromide boehringer ingelheim 1 s 30-jan-04 1186 z n021540 caduet amlodipine besylate; atorvastatin calcium pfizer 4 s 30-jan-04 n021625 mvi adult multi-vitamins aaipharma 3 s 30-jan-04 1180 n021462 alimta pemetrexed disodium eli lilly 1 p, o 04-feb-04 n021594 amiodarone hydrochloride amiodarone hydrochloride international medication sys 5 s 04-feb-04 n021644 clobex clobetasol propionate galderma labs 3 s 05-feb-04 n021166 estrogel estradiol solvay pharms 3 s 09-feb-04 n021590 fazaclo clozapine alamo pharms 3 s 10-feb-04 z n021643 mvi adult multi-vitamins aaipharma 3 s 18-feb-04 z n021587 children's advil allergy sinus ibuprofen; pseudophedrine hydrochloride; chlorpheniramine maleate wyeth cons 3 s 24-feb-04 n050791 myfortic mycophenolic acid novartis pharms 2 s 27-feb-04 n021571 iquix levofloxacin santen 3 s 01-mar-04 1192 n021688 sensipar cinacalcet hydrochloride amgen 1 p, o 08-mar-04 n021621 zyrtec cetirizine hydrochloride pfizer 3 s 16-mar-04 n021211 follistim aq follitropin beta organon 3 s 23-mar-04 n021765 gonal-f follitropin alfa serono inc 3 s 25-mar-04 n021253 zyprexa im olanzapine eli lilly 3 s 29-mar-04 1189 n021144 ketek telithromycin aventis pharms 1 s 01-apr-04 n020784 nasacort hfa triamcinolone acetonide aventis pharms 3 s 07-apr-04 n021256 chirhostim human secretin chirhoclin 1 p 09-apr-04 n021629 apidra insulin glulisine aventis pharms 1 s 16-apr-04 1200 n021264 apokyn apomorphine hydrochloride bertek 1 p, o 20-apr-04 n021574 fortamet metformin hydrochloride andrx 5 s 27-apr-04 n021640 vitrase ovine hyaluronidase ista pharms 1 p 05-may-04 n021504 lidosite topical system lidocaine hydrochloride; epinephrine vyteris 3 s 06-may-04 n021617 zalkote valproate sodium andrx 3 s 06-may-04 * n021443 enjuvia synthetic conjugated estrogens, b duramed 3 s 10-may-04 z n021551 halflytely and bisacodyl bowel prep kit peg-3350; sodium chloride; sodium bicarbonate; potassium chloride; bisacodyl braintree 3 s 10-may-04 n021433 flovent hfa fluticasone propionate glaxosmithkline 3 s 14-may-04 1190 n021618 tindamax tinidazole presutti labs 1 s 17-may-04 n021671 depodur morphine sulfate skye pharma 3 s 18-may-04 1201 n050794 vidaza azacitidine pharmion 1 p, o 19-may-04 1191 n021361 xifaxan rifaximin salix pharms 1 s 25-may-04 n021494 axid nizatidine reliant pharma 3 s 25-may-04 n021684 gonal-f rff pen follitropin alfa serono inc 3 s 25-may-04 n021566 prevacid iv lansoprazole tap pharm 3 s 27-may-04 1188 n021595 sanctura trospium chloride indevus 1 s 28-may-04 n021530 mobic meloxicam boehringer ingelheim 3 s 01-jun-04 n021516 istalol timolol maleate senju 3 s 04-jun-04 n021667 nutresore l-glutamine nutritional restart 1 s, o 10-jun-04 1206 n021636 zegerid omeprazole santarus 3 s 15-jun-04 z n021369 codeprex codeine polistirex; chlorpheniramine polistirex celltech pharms 3 s 21-jun-04 z n021585 mucinex d guaifenesin; pseudoephedrine hydrochloride adams 3 s 22-jun-04 n021512 loratadine loratadine perrigo 3 s 24-jun-04 n050789 tobramycin tobramycin american pharm 5 s 13-jul-04 n021612 luxacor fenofibrate cipher 3 s 15-jul-04 * n021497 alinia nitazoxanide romark 3 p 21-jul-04 1191 z n021687 vytorin ezetimibe; simvastatin msp singapore 4 s 23-jul-04 n021415 metvix methyl aminolevulinate photocure asa 3 s 27-jul-04 1199 n021431 campral acamprosate calcium lipha 1 p 29-jul-04 n050792 cefotaxime and dextrose duplex container cefotaxime sodium b braun 5 s 29-jul-04 1203 z n021652 epzicom abacavir sulfate; lamivudine glaxosmithkline 3 s 02-aug-04 1203 z n021752 truvada emtricitabine; tenofovir disoproxil fumarate gilead sciences 4 p 02-aug-04 1193 n021427 cymbalta duloxetine hydrochloride eli lilly 1 s 03-aug-04 n021768 fludeoxyglucose f18 fludeoxyglucose f18 weill medical college 3 s 05-aug-04 n021749 pentetate calcium trisodium pentetate calcium trisodium pharma hameln gmbh 1 p, o 11-aug-04 n021751 pentetate zinc trisodium pentetate zinc trisodium pharma hameln gmbh 1 p, o 11-aug-04 n021633 femtrace estradiol acetate warner chilcott 3 s 20-aug-04 n021648 digoxin digoxin roxane 7 s 26-aug-04 n021678 tequin gatifloxacin bristol-myers squibb 3 s 27-aug-04 n021698 zantac ranitidine hydrochloride pfizer consumer healthcare 3 s 31-aug-04 n021300 clarinex desloratadine schering 3 s 01-sep-04 n021563 clarinex desloratadine schering 3 p 01-sep-04 n021712 fluxid famotidine schwarz pharma 3 s 24-sep-04 1204 n021044 palladone hydromorphone hydrochloride purdue pharma 3 s 24-sep-04 n021727 amlexanox amlexanox access pharms 3 s 29-sep-04 n021735 terconazole terconazole altana 5 s 01-oct-04 n021322 luveris lutropin alfa serono inc 3 s, o 08-oct-04 n021732 vantas histrelin acetate valera 3 s 12-oct-04 n021683 manoplex insoluble prussian blue degussa 5 p 14-oct-04 * n021719 aricept donepezil hydrochloride eisai medical 3 s 18-oct-04 n021720 aricept donepezil hydrochloride eisai medical 3 s 18-oct-04 z n021704 allegra-d 24 hour fexofenadine hydrochloride; pseudoephedrine hydrochloride aventis pharms 3 s 19-oct-04 n021721 levaquin levoflaxin ortho mcneil 3 s 21-oct-04 n050801 evoclin clindamycin phosphate connetics 3 s 22-oct-04 * 1228 n021468 fosrenol lanthanum carbonate hydrate shire pharm 1 s 26-oct-04 z n021486 lidocaine hydrochloride; epinephrine lidocaine hydrochloride; epinephrine empi 4 s 26-oct-04 n021665 amphadase hyaluronidase amphastar pharm 1 p 26-oct-04 n021736 xamlom amlodipine ranbaxy res 3 s 28-oct-04 * n021457 albuterol sulfate albuterol sulfate ivax res 3 s 29-oct-04 n021663 menopur menotropins ferring 3 s 29-oct-04 n021656 tricor fenofibrate abbott 3 s 05-nov-04 n021654 omacor omega-3-acid ethyl esters ross prods 1 s 10-nov-04 n021527 atrovent hfa ipratropium bromide boehringer ingelheim 3 s 17-nov-04 1205 n021743 tarceva erlotinib hydrochloride osi pharms 1 p 18-nov-04 1204 n021518 vesicare solifenacin succinate yamanouchi 1 s 19-nov-04 n021357 multihance gadobenate dimeglumine bracco 1 s 23-nov-04 n021358 multihance multipack gadobenate dimeglumine bracco 3 s 23-nov-04 z n021378 combunox ibuprofen; oxycodone hydrochloride forest labs 4 s 26-nov-04 n021695 antara fenofibrate reliant pharms 3 s 30-nov-04 n050793 clindesse clindamycin phosphate kv pharm 5 s 30-nov-04 n021786 kelacal pentetate calcium trisodium cis 5 p 01-dec-04 * n021787 kelazin pentetate zinc trisodium cis 5 p 01-dec-04 * n021713 abilify aripiprazole otsuka america 3 s 10-dec-04 n021731 eligard leuprolide acetate atrix 3 s 14-dec-04 z n050804 zylet loteprednol etabonate; tobramycin bausch and lomb 4 s 14-dec-04 1203 n021476 lunesta eszopicline sepracor 1 s 15-dec-04 n021670 vision blue trypan blue dorc international bv 1 p 16-dec-04 n021583 depo-subq provera 104 medroxyprogesterone acetate pfizer 3 s 17-dec-04 1212 n021756 macugen pegaptanib sodium eyetech pharms 1 p 17-dec-04 n021785 invirase saquinavir mesylate roche 3 p 17-dec-04 n021609 enjuvia synthetic conjugated estrogens, b duramed pharms 3 s 20-dec-04 n021706 omeprazole omeprazole santarus 3 s 21-dec-04 1204 n021513 enablex darifenacin hydrobromide novartis 1 s 22-dec-04 n021545 olopatadine hydrochloride olopatadine hydrochloride alcon 3 s 22-dec-04 n021615 reminyl galantamine hydrochloride johnson and johnson 3 s 22-dec-04 n021060 prialt ziconotide elan pharms 1 p 28-dec-04 n021673 clolar clofarabine genzyme 1 p, o 28-dec-04 n021779 ventavis iloprost cotherix 1 p, o 29-dec-04 n021446 lyrica pregabalin pfizer 1 p 30-dec-04 blaf ml bla number proprietary name proper name applicant rc approval date bl125084 erbitux cetuximab imclone systems p 12-feb-04 bl125085 avastin bevacizumab genentech p 26-feb-04 z bl125083 pegasys copegus combination pack peginterferon alfa-2a co-packaged with ribavirin hoffmann-la roche s 04-jun-04 bl103928 neutrospec technetium 99m tc fanolesomab palatin technologies s 02-jul-04 1202 1204 bl125104 tysabri natalizumab biogen idec inc p 23-nov-04 1207 bl125103 kepivance palifermin amgen, inc p 15-dec-04 nda approvals for calendar year 2003 ml nda number drug name generic name applicant sponsor ct rc approval date 1157 21434 xanax xr alprazolam pharmacia and upjohn fr 3 s 17-jan-03 21305 sodium iodide i-131 sodium iodide i-131 draximage 3, 5 s 24-jan-03 20414 pyridostigmine bromide pyridostigmine bromide us army 3 p 05-feb-03 21392 cardizem la diltiazem hydrochloride biovail 3 s 06-feb-03 21488 eligard leuprolide acetate atrix 3 s 13-feb-03 1156 21351 oxytrol oxybutynin watson labs utah ; 3 s 26-feb-03 21159 loprox ciclopirox medicis 3 s 28-feb-03 21438 innopran xl propranolol hydrochloride reliant pharms 5 s 12-mar-03 1159 21481 fuzeon enfuvirtide roche 1 p 13-mar-03 21367 femring estradiol acetate galen ltd 2 s 20-mar-03 1160 21106 somavert pegvisomant pharmacia and upjohn 1 pv 25-mar-03 1162 21549 emend aprepitant merck 1 p 26-mar-03 1179 21493 zymar gatifloxacin allergan 3 s 28-mar-03 21444 risperdal risperidone johnson & johnson 3 s 02-apr-03 1192 21158 factive gemifloxacin mesylate lg life 1 s 04-apr-03 21271 iprivask desirudin aventis pharms 2 s 04-apr-03 21475 methylin methylphenidate hydrochloride mallinckrodt 3 s 15-apr-03 1179 21598 vigamox moxifloxacin hydrochloride alcon 3 s 15-apr-03 1106 21588 gleevec imatinib mesylate novartis 3 p 18-apr-03 21503 viracept nelfinavir mesylate agouron 3 s 30-apr-03 1138 21399 iressa gefitinib astrazeneca 1 p 05-may-03 1161 21602 velcade bortezomib millennium pharms 1 p 13-may-03 1207 21-455 boniva ibandronate sodium roche 1 s 16-may-03 z 21-496 duocaine bupivacaine hydrochloride; lidocaine hydrochloride amphastar pharms 4 s 23-may-03 20-800 twinject epinephrine hollister-stier labs 3 s 30-may-03 21-528 acular ls ketorolac tromethamine allergan 3 s 30-may-03 z 21-396 prempro premphase conjugated estrogens; medroxyprogesterone acetate wyeth pharms 3 s 04-jun-03 z 21-532 benicar hct olmesartan medoxomil; hydrochlorothiazide sankyo pharma 4 s 05-jun-03 21-137 levolet levothyroxine sodium vintage pharms 5 s 06-jun-03 1182 z 21-485 stalevo carbidopa; levodopa; entacapone orion 4 s 11-jun-03 1173 21-287 uroxatral alfuzosin hydrochloride sanofi synthelabo 1 s 12-jun-03 21-559 infuvite adult multiple vitamins sabex 5 s 16-jun-03 21-543 striant testosterone columbia labs 3 s 19-jun-03 21-229 prilosec omeprazole magnesium astrazeneca lp 2, 3 s 20-jun-03 1169 21-567 reyataz atazanavir sulfate bristol myers squibb 1 p 20-jun-03 z 21-387 pravigard pac aspirin; pravastatin sodium bristol myers squibb 4 s 24-jun-03 1169 21500 emtriva emtricitabine gilead 1 s 02-jul-03 21299 paroxetine mesylate paroxetine mesylate synthon pharms 2 s 03-jul-03 20452 paraplatin carboplatin bristol myers squibb 3 s 14-jul-03 21505 keppra levetiracetam ucb 3 s 15-jul-03 z 21537 ciprodex ciprofloxacin; dexamethasone alcon 3 s 18-jul-03 21535 clobex clobetasol propionate galderma labs lp 3 s 24-jul-03 1179 21372 aloxi palonosetron hydrochloride helsinn hlthcare 1 s 25-jul-03 21546 rebetol ribavirin schering 3 p 29-jul-03 21348 zavesca miglustat actelion pharms 1 sv 31-jul-03 1167 21366 crestor rosuvastatin calcium ipr 1 s 12-aug-03 1166 21400 levitra vardenafil hydrochloride bayer 1 s 19-aug-03 21515 wellbutrin xl bupropion hydrochloride glaxosmithkline 3 s 28-aug-03 21416 rythmol sr propafenone hydrochloride abbott 3 s 04-sep-03 1175 z 21544 seasonale ethinyl estradiol; levonorgesterol barr 3 s 05-sep-03 21591 riomet metformin hydrochloride ranbaxy 3 s 11-sep-03 1175 21572 cubicin daptomycin cubist pharms 1 p 12-sep-03 21575 fosamax alendronate sodium merck 3 s 17-sep-03 1174 21450 zomig zolmitriptan astrazeneca 3 s 30-sep-03 21626 radiogardase prussian blue heyl chemisch- pharmazeutische fabrik gmbh 1 pv 02-oct-03 21371 estrasorb estradiol novavax 3 s 09-oct-03 21489 prohance gadoteridol bracco 3 s 09-oct-03 21487 namenda memantine hydrochloride forest labs 1 s 16-oct-03 21565 elestat epinastine hydrochloride allergan 1 s 16-oct-03 21548 lexiva fosamprenavir calcium glaxosmithkline 2 s 20-oct-03 21346 risperdal consta risperidone johnson and johnson 3 s 29-oct-03 21589 kemstro baclofen schwarz pharma 3 s 30-oct-03 21435 amvaz amlodipine maleate dr reddys labs inc 2 s 31-oct-03 z 21490 ovcon 35 ethinyl estradiol; norethindrone warner chilcott 3 s 14-nov-03 z 21507 prevacid; naprapac lansoprozole; naproxen tap pharm 4 s 14-nov-03 z 21258 climara pro estradiol; levonorgestrel berlex labs 4 s 21-nov-03 1172 21368 cialis tadalafil lilly icos 1 s 21-nov-03 1178 21320 plenaxis abarelix praecis 1 p 25-nov-03 1185 21385 ertaczo sertaconazole nitrate mylan pharms 1 s 10-dec-03 21388 sterile talc powder sterile talc powder bryan corp 3 pv 15-dec-03 z 21451 oraqix lidocaine; prilocaine dentsply pharms 4 s 19-dec-03 1135 21630 vfend voriconazole pfizer inc 3 s 19-dec-03 1178 z 21520 symbyax olanzapine; fluoxetine hydrochloride eli lilly 4 p 24-dec-03 nda approvals for calendar year 2002 ml nda number drug name generic name applicant sponsor ct tc approval date z 21-175 atnaa atropine; pralidoxime chloride us army 3 p 17-jan-02 z 21-112 tri-luma fluocinolone acetonide; hydroquinone; tretinoin hill dermaceuticals 4 s 18-jan-02 21-232 orfadin nitisinone swedish orphan 1 pv 18-jan-02 21-343 eligard leuprolide acetate atrix 3 s 23-jan-02 21-360 sustiva efavirenz bristol myers squibb 3 s 01-feb-02 21-342 levo-t levothyroxine sodium mova 5 s 01-mar-02 21-113 pamidronate disodium pamidronate disodium bedford 5 s 04-mar-02 21-299 asimia paroxetine mesylate synthon pharms 2 s 11-mar-02 21-260 avinza morphine sulfate elan pharm 3 s 20-mar-02 20-855 mesnex mesna bristol myers squibb 3 s 21-mar-02 21-136 secreflo secretin chirhoclin 3 sv 04-apr-02 21-209 secreflo secretin chirhoclin 3 * pv 04-apr-02 21-310 alora estradiol watson labs 3 s 05-apr-02 z 21-373 children's advil cold ibuprofen; pseudoephedrine hcl wyeth consumer healthcare 3 s 18-apr-02 1136 21-286 benicar olmesartan medoxomil sankyo 1 s 25-apr-02 1135 21-344 faslodex fulvestrant astrazeneca 1 s 25-apr-02 21-289 bravelle urofollitropin ferring 3 s 06-may-02 1139 21-272 remodulin treprostinil sodium united therapeutics 1 pv 21-may-02 1135 21-266 vfend voriconazole pfizer 1 s 24-may-02 1135 21-267 vfend voriconazole pfizer 3 s 24-may-02 50784 zithromax azithromycin dihydrate pfizer 3 s 24-may-02 z 21-374 advil cold sinus ibuprofen; pseudoephedrine hcl wyeth consumer healthcare 3 s 30-may-02 z 21-191 imagent kit for the preparation of perflexane lipid microspheres dimyristoylphosphatidylcholine; perflexane alliance pharm 1 s 31-may-02 21-292 novothyrox levothyroxine sodium genpharm 5 s 31-may-02 21-284 ritalin la methylphenidate hcl novartis pharm 3 s 05-jun-02 0958 21-212 caverject alprostadil pharmacia & upjohn 3 s 11-jun-02 1106 20919 geodon ziprasidone mesylate pfizer 3 s 21-jun-02 21-312 clarinex reditabs desloratadine schering 3 s 26-jun-02 1151 21-316 altocor lovastatin aura labs 3 s 26-jun-02 21-282 mucinex guaifenesin adams labs 3 s 12-jul-02 1145 21-196 xyrem sodium oxybate orphan medical 1 pv 17-jul-02 1139 21-200 zelnorm tegaserod maleate novartis pharms 1 p 24-jul-02 * 1132 21-379 eligard leuprolide acetate atrix 3 s 24-jul-02 21-402 synthroid levothyroxine sodium abbott labs 5 s 24-jul-02 21-409 singulair montelukast sodium merck research 3 s 26-jul-02 1148 21-492 eloxatin oxaliplatin sanofi-synthelabo 1 p 09-aug-02 1140 21-323 lexapro escitalopram oxalate forest labs 3 s 14-aug-02 21-241 ortho tri cyclen ethinyl estradiol; norgestimate johnson & johnson 3 s 22-aug-02 z 50741 duac clindamycin phosphate; benzoylperoxide stiefel labs 4 s 26-aug-02 1004 21-447 zanaflex tizanidine hcl elan pharms 3 s 29-aug-02 21-428 prevacid lansoprazole tap 3 s 30-aug-02 21-333 desmopressin acetate desmopressin acetate ferring pharms 5 s 16-sep-02 21-425 ultravist iopromide berlex labs 3 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pulmicort respules budesonide astra 3 p 08-aug-00 21-197 cetrotide cetrorelix acetate asta medica 1 s 11-aug-00 21-167 vivelle estradiol novartis 3 s 16-aug-00 21-199 quixin levofloxacin santen inc 3 p 18-aug-00 21-210 unithroid levothyroxine sodium jerome stevens pharm 7 s 21-aug-00 1102 z 21-077 advair diskus fluticasone propionate salmeterol xinafoate glaxo wellcome 4 s 24-aug-00 1071 21-110 rapamune sirolimus wyeth-ayerst 3 s 25-aug-00 21-108 renova tretinoin johnson & johnson 3 s 31-aug-00 1113 21-011 roxicodone oxycodone hcl roxane labs 3 s 31-aug-00 z 21-093 atacand hct candesartan cilexetil hydrochlorothiazide astrazeneca 4 s 05-sep-00 20-911 qvar beclomethasone dipropionate 3m pharm 3 s 15-sep-00 1095 z 21-226 kaletra lopinavir ritonavir abbott labs 14 p 15-sep-00 1095 z 21-251 kaletra lopinavir ritonavir abbott labs 34 p 15-sep-00 21-149 ovidrel choriogonadotropin alfa serono lab 3 s 20-sep-00 z 21-097 visicol sodium phosphate dibasic anyhyrdous sodium phosphate monobasic 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21-162 micardis hct hydrochlorothiazide telmisartan boehringer pharms 4 s 17-nov-00 50-782 clindamycin clindamycin phosphate clindagel 3 s 27-nov-00 z 50-769 benzamycin pak benzoylperoxide erythromycin dermik labs 3 s 27-nov-00 z 21-140 imodium advanced loperamide hcl simethicone mcneil cons 3 s 30-nov-00 1096 21-225 mirena levonorgestrel berlex labs 3 s 06-dec-00 z 20-010 lotrisone betamethasone diproprionate clotrimazole schering-plough 34 s 08-dec-00 1102 50-777 protopic tacrolimus fujisawa healthcare 3 s 08-dec-00 1063 21-246 tamiflu oseltamivir phosphate hoffmann-la roche 3 p 14-dec-00 1103 20-873 angiomax bivalirudin the medicines co 1 s 15-dec-00 21-190 buspar buspirone hydrochoride bristol myers squibb 3 s 20-dec-00 z 21-090 cyclessa desogestrel ethinyl estradiol organon 3 s 20-dec-00 z 50-756 benzaclin benzoylperoxide clindamycin dermik labs 4 s 21-dec-00 1101 21-204 starlix nateglinide novartis pharms 1 s 22-dec-00 1101 21-228 detrol la tolterodine tartrate pharmacia & upjohn 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26-mar-99 0966 20-966 sporanox itraconazole janssen 3 s 30-mar-99 21-041 depocyt cytarabine skye pharma 3 p 01-apr-99 z 20-924 cernevit-12 multivitamins baxter hlthcare 3 s 06-apr-99 1057 21-007 agenerase amprenavir glaxo wellcome 1 p 15-apr-99 1057 21-039 agenerase amprenavir glaxo wellcome 3 p 15-apr-99 50-760 amoxil amoxicillin skb pharms 3 s 15-apr-99 50-761 amoxil amoxicillin skb pharms 3 s 15-apr-99 1055 20-766 xenical orlistat roche 1 p 23-apr-99 1056 21-042 vioxx rofecoxib merck res 1 p 20-may-99 1056 21-052 vioxx rofecoxib merck res 3 p 20-may-99 1059 21-071 avandia rosiglitazone maleate skb pharms 1 p 25-may-99 20-862 hectorol doxercalciferol bone care 1 s 09-jun-99 20-945 norvir ritonavir abbott labs 3 s 29-jun-99 20-968 monistat dual- pak miconazole nitrate advanced care prods 3 s 30-jun-99 1077 21-066 zaditor ketotifen fumarate ciba vision 1 p 02-jul-99 20-951 tagamet cimetidine skb cons hlthcare 3 s 09-jul-99 1066 21-073 actos pioglitazone hcl takeda america 1 p 15-jul-99 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bayer 4 s 29-nov-99 1076 21-035 keppra levetiracetam ucb pharma 1 s 30-nov-99 1133 20-965 levulan kerastick aminolevulinic acid hcl dusa pharma 1 s 03-dec-99 20-990 zoloft sertraline hcl pfizer 3 s 07-dec-99 20-937 optimark gadoversetamide mallinckrodt 1 s 08-dec-99 20-975 optimark gadoversetamide mallinckrodt 3 s 08-dec-99 20-976 optimark gadoversetamide mallinckrodt 3 s 08-dec-99 1077 21-009 alocril nedocromil sodium allergan 3 p 08-dec-99 z 20-922 solage mequinol tretinoin bristol-myers squibb 1, 4 s 10-dec-99 1072 21-085 avelox moxifloxacin hcl bayer 1 s 10-dec-99 21-092 helicosol c-13 urea metabolic solution 5 s 17-dec-99 1080 21-022 penlac nail lacquer ciclopirox aventis pharms 3 s 17-dec-99 21-038 precedex dexmedetomidine hcl abbott labs 1 s 17-dec-99 1072 21-061 tequin gatifloxacin bristol myers squibb 1 s 17-dec-99 1072 21-062 tequin gatifloxacin bristol myers squibb 3 s 17-dec-99 1041 21-046 celexa citalopram hydrobromide forest labs 3 s 22-dec-99 z 21-017 humalog mix 75 25 insulin lispro insulin lispro protamine eli lilly 3, 4 s 22-dec-99 z 21-018 humalog mix 50 insulin lispro insulin lispro protamine eli lilly 3, 4 s 22-dec-99 21-075 nutropin depot somatropin genentech 3 pv 22-dec-99 20-845 ino max nitric oxide ino therapeutics 1 pv 23-dec-99 z 20-125 accuretic quinapril hctz parke-davis 4 s 28-dec-99 21-055 targretin bexarotene ligand pharm 1 pv 29-dec-99 ml nda number drug name generic name applicant # approval date dosage form nda approvals for calendar year 1998 20-181 liposyn iii soybean oil abbott labs 3 s 13-jan-98 injection z 20-802 excedrin acetaminophen aspirin caffeine bristol myers 7 s 14-jan-98 tablet 1028 20-697 tasmar tolcapone hoffman la-roche 1 s 29-jan-98 tablet 20-812 pediatric advil ibuprofen whitehall robins 3 s 30-jan-98 suspension 50-731 daunorubicin hcl daunorubicin hcl bedford labs 3 s 30-jan-98 injection z 20-962 emla lidocaine prilocaine astra pharms 3 s 4-feb-98 disc 1037 20-763 amerge naratriptan hcl glaxo wellcome 1 s 10-feb-98 tablet z 20-805 cipro hc ciprofloxacin hcl hydrocortisone bayer 3 s 10-feb-98 suspension 1031 20-829 singulair montelukast sodium merck 1 s 20-feb-98 tablet 1031 20-830 singulair montelukast sodium merck 3 s 20-feb-98 tablet z 50-750 zosyn piperacillin sodium tazobactam sodium lederle 3 s 24-feb-98 injection 20-745 zantac 75 ranitidine hcl glaxo wellcome 3 s 26-feb-98 tablet 20-906 etopophos etoposide phosphate bristol myers squibb 3 s 27-feb-98 injection 1036 20-807 refludan lepirudin hoechst marion rssl 1 p 6-mar-98 injection z 20-818 diovan hct hydrochlorothiazide valsartan novartis pharms 4 s 6-mar-98 tablet 20-583 lotemax loteprednol etabonate pharmos 1 s 9-mar-98 suspension 20-803 alrex loteprednol etabonate pharmos 3 s 9-mar-98 suspension 1038 20-771 detrol tolterodine tartrate pharmacia & upjohn 1 s 25-mar-98 tablet 1034 20-835 actonel risedronate sodium procter & gamble pharm 1 s 27-mar-98 tablet 1026 20-895 viagra sildenafil citrate pfizer 1 p 27-mar-98 tablet 20-369 ciloxan ciprofloxacin hcl alcon 3 s 30-mar-98 ointment 20-827 monistat 3 miconazole nitrate advanced care 3 s 30-mar-98 cream 1036 20-816 azopt brinzolamide alcon 1 s 1-apr-98 suspension z 20-869 cosopt dorzolamide hcl timolol maleate merck res 4 s 7-apr-98 solution 20-772 sucraid sacrosidase orphan medcl 1 p 9-apr-98 solution 20-819 zemplar paricalcitol abbott lab 1 s 17-apr-98 injection 20-713 mircette desogestrel ethinyl estradiol organon 3 s 22-apr-98 tablet 20-846 lamisil terbinafine novartis pharms 3 s 29-apr-98 gel 1039 20-896 xeloda capecitabine hoffman la-roche 1 p 30-apr-98 tablet 20-809 diclofenac sodium diclofenac sodium falcon pharms 3 s 4-may-98 solution 19-781 prometrium progesterone schering plough 3 s 14-may-98 capsule 1035 20-912 aggrastat tirofiban hcl merck 1p 14-may-98 injection 1035 20-913 aggrastat tirofiban hcl merck 3p 14-may-98 injection 20-774 periochip chlorhexidine gluconate perio prods 3 s 15-may-98 tablet 1035 20-718 integrilin eptifibatide cor 1 p 18-may-98 injection 20-752 pepcid rpd famotidine merck 3 s 28-may-98 tablet 20-923 optiray ioversol mallinckrodt medcl 3 s 29-may-98 injection 20-903 rebetol ribavirin schering plough res 3 p 3-jun-98 capsule 1040 20-838 atacand candesartan cilexetil astra merck pharms 1 s 4-jun-98 tablet 19-832 sulfamylon mafenide acetate mylan pharms 3 s 5-jun-98 powder, for reconstitution 20-918 glucagen glucagon hcl recombinant novo nordisk pharm 3 p 22-jun-98 injection 1047 21-024 priftin rifapentine hoechst marion rssl 1 p 22-jun-98 tablet 1037 20-864 maxalt rizatriptan benzoate merck 1 s 29-jun-98 tablet 1037 20-865 maxalt rizatriptan benzoate merck 3 s 29-jun-98 tablet 50-754 amoxil amoxicillin skb pharms 3 s 10-jul-98 tablet z 20-860 levlite ethinyl estradiol levonorgestrel berlex labs 3 s 13-jul-98 tablet 1038 20-785 thalomid thalidomide celgene 1 p 16-jul-98 capsule 1041 20-822 celexa citalopram hydrobromide forest labs 1 s 17-jul-98 tablet 20-847 esclim estradiol fournier res 3 s 4-aug-98 film, controlled release z 20-870 combipatch estradiol norethindrone acetate rhone poulenc rorer 3 s 7-aug-98 film, controlled release 50-758 cellcept mycophenolate mofetil hcl glaxosmithkline 3 s 12-aug-98 injection 20-764 lamictal cd lamotrigine glaxo wellcome 3 s 24-aug-98 tablet 20-849 prosol 20% sulfite free in plastic container amino acids baxter hlthcare 3 s 26-aug-98 injection 20-961 vitravene preservative free fomivirsen sodium novartis 1 p 26-aug-98 injection 20-946 preven ethinyl estradiol levonorgestrel gynetics 3 p 1-sep-98 tablet 50-751 atridox doxycycline hyclate atrix 3 s 3-sep-98 liquid, extended release 1040 20-905 arava leflunomide aventis pharms 1 p 10-sep-98 tablet 20-928 glucagon glucagon, recombinant lilly 3 p 11-sep-98 injection 20-933 viramune nevirapine boehringer pharms 3 p 11-sep-98 suspension 20-887 acutect technetium tc-99m apcitide diatide 1 p 14-sep-98 injection 1041 20-972 sustiva efavirenz dupont pharms 1 p 17-sep-98 capsule 20-801 pepcid ac famotidine merck res 3 s 24-sep-98 tablet 1049 20-892 valstar valrubicin anthra 1 p 25-sep-98 solution 50-744 periostat doxycycline hyclate collagenex 3 s 30-sep-98 capsule 0958 50-759 cellcept mycophenolate mofetil roche global dev 3 s 1-oct-98 suspension 20-882 neurontin gabapentin parke davis 3 s 9-oct-98 tablet 20-885 paxil paroxetine hcl skb pharms 3 s 9-oct-98 capsule 20-942 versed midazolam hcl hoffman la-roche 3 p 15-oct-98 syrup 20-963 timolol maleate timolol maleate falcon pharms 3 s 21-oct-98 solution 1001 20-844 topamax topiramate johnson rw 3 s 26-oct-98 capsule 20-932 roxicodone oxycodone hcl roxane 3 s 26-oct-98 tablet 20-773 sonorx simethicone-cellulose bracco dxs 3 s 29-oct-98 suspension 20-926 renagel sevelamer hcl geltex pharm 1 s 30-oct-98 capsule 20-747 actiq fentanyl citrate anesta 3 s 4-nov-98 troche lozenge 1065 20-850 micardis telmisartan boehringer ingelheim 1 s 10-nov-98 tablet z 20-907 activelle estradiol norethindrone acetate novo nordisk 4 s 18-nov-98 tablet 21-068 rocaltrol calcitriol roche 3 s 20-nov-98 solution 20-574 gyne-lotrimin 3 clotrimazole schering plough 3 s 24-nov-98 cream 20-901 metrolotion metronidazole galderma 3 s 24-nov-98 lotion 21-008 sandostatin lar octreotide acetate novartis pharm 3 p 25-nov-98 injection 20-943 verelan verapamil hcl elan pharm 3 s 25-nov-98 capsule 20-898 thyrogen thyrotropin alfa genzyme 1 p 30-nov-98 injection 20-843 prometrium progesterone schering plough 3 s 16-dec-98 capsule 1101 20-897 ditropan xl oxybutynin chloride alza 3 s 16-dec-98 tablet 1041 20-977 ziagen abacavir sulfate glaxo wellcome 1 p 17-dec-98 tablet 1041 20-978 ziagen abacavir sulfate glaxo wellcome 3 p 17-dec-98 solution 20-944 advil ibuprofen whitehall robins 3 s 18-dec-98 tablet z 50-762 trovan\zithromax compliance pak azithromycin dihydrate trovafloxacin mesylate pfizer 4 s 18-dec-98 for suspension; tablet 1049 20-717 provigil modafinil cephalon 1 s 24-dec-98 tablet 1045 20-998 celebrex celecoxib searle 1 p 31-dec-98 capsule * nda 21209, secreflo - chemical type for this drug product is a 6 but for repo rting purposes original reports are not changed. World Federation of Neurology WFN ; was founded in 1957 by representatives from 21 countries present at the International Congress of Neurological Sciences in Brussels. Most of the founding fathers came from Western countries. Their intention was to promote the dissemination of information and scientific knowledge in the neurosciences, to foster collaborative international programmes of clinical and basic neurological research, and to promote high standards of neurological care and develop improved services in developing countries 1 ; . Since then, international collaboration in medicine has changed. In 1957, only 12 years had passed since World War II ended. Harold Macmillan was elected British Prime Minister in 1957 and three years later, in 1960, he gave his famous "Winds of Change" speech, predicting growth of national consciousness and dramatic changes of the world atlas as it was known then. The WFN was founded the same year as Sputnik 1 was sent out, four years before the Berlin wall was built and before national independence of so many former colonies. In 1957, United Nations had 81 member states; in 2003 there are 192. The winds of change have also swept over neurology. Neurological research has become more international, and the global network between universities and research institutions is much more elaborated than it was in 1957. Regional neurological organisations exist; most of them with a well developed infrastructure, and with annual meetings and conferences allowing for strong scientific and personal ties across boundaries. The role of WFN in research co-ordination is therefore different from what it was in 1957 and is more focused upon inclusion of countries in transition. The purpose of WFN is to improve human health worldwide by promoting prevention and the care of persons with disorders of the entire nervous system by fostering the best standards of neurological practice; educating, in collaboration with neuroscience and other international public and private organisations; and.
Table 2. Annual percent change in lumbar spine and hip BMD in men with prostate carcinoma receiving ADT in randomized controlled trials Annual BMD change % ; Study Diamond et al. [39] Smith et al. [27] Diamond et al. [40] Smith et al. [28] n of patients 12 47 21 Treatment CAB alone + etidronate 400 mg oral daily for 2 weeks q 3 months ; CAB alone + pamidronate 60 mg q 3 months ; CAB alone + pamidronate 90 mg single infusion ; GnRH agonist alone antiandrogen ; + zoledronic acid 4 mg q 3 months ; LS DEXA - - 3.3 + 0.5 - - 2.2 + 5.6 LS QCT 6.6 + 7.8 8.5 2.0 + 7.8 - - Hip DEXA 6.5 2.4 1.8 + 0.2 2.3 + 2.0 2.8 + 1.1.