[Federal Register Volume 63, Number 95 (Monday, May 18, 1998)]
[Notices]
[Pages 27300-27303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13045]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0286]
Environmental Assessments and Findings of No Significant Impact
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
has reviewed environmental assessments (EA's) and issued findings of no
significant impact (FONSI's) relating to the 167 new drug applications
(NDA's) and supplemental applications listed in this document. FDA is
publishing this notice because Federal regulations require public
notice of the availability of environmental documents.
ADDRESSES: The EA's and FONSI's may be seen in the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857, or a copy may be requested by writing the
Freedom of Information Staff (HFI-35), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug
Evaluation and Research (HFD-357), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5629.
SUPPLEMENTARY INFORMATION: Under the National Environmental Policy Act
of 1969 (NEPA), Congress declared that it will be the continuing policy
of the Federal Government to ``use all practicable means and measures,
including financial and technical assistance, in a manner calculated to
foster and promote the general welfare, to create and maintain
conditions under which man and nature can exist in productive harmony,
and fulfill the social, economic and other requirements of present and
future generations of Americans.'' (See 42 U.S.C. 4331(a).) NEPA
requires all Federal agencies to include in every proposal for major
Federal actions significantly affecting the quality of the human
environment, a detailed statement assessing the environmental impact
of, and alternatives to, the proposed action and to make available to
the public such statements. (See 42 U.S.C. 4332, 40 CFR 1506.6, and 21
CFR 25.51(b).)
FDA implements NEPA through its regulations in part 25 (21 CFR part
25). Under those regulations, actions to approve NDA's, abbreviated new
drug applications (ANDA's), and supplements to existing approvals
ordinarily require the preparation of an EA. (See Sec. 25.20(l).)
FDA approved 167 NDA's and supplemental NDA's and ANDA's for the
products listed in the following table:
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Drug Application Number
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Klonopin (clonazepam) Tablets 17-533/S-023
Ativan (lorazepam) Injection 18-140/S-003
Rythmol (propafenone hydrochloride) Tablets 19-151/S-002
Novantrone (mitoxantrone hydrochloride) for Injection 19-297/S-014
Actigall (ursodiol) Capsules 19-594/S-016
Humatrope (somatropin) for Injection 19-640/S-013 and S-018
Asacol (mesalamine) Tablets 19-651/S-005
Tilade (nedocromil sodium) Inhalation Aerosol 19-660/S-015
Zoladex (goserelin acetate) Implant 19-726/S-018
Prilosec (omeprazole) Capsules 19-810/S-036
Soriatane (acitretin) Capsules 19-821
Zoloft (sertraline hydrochloride) Tablets 19-839/S-002 and S-011
Corlopam (fenoldopam mesylate) for Injection 19-922
Zofran (ondansetron hydrochloride) Tablets 20-103/S-005
Astelin (azelastine hydrochloride) Nasal Spray 20-114
Migranal (dihydroergotamine mesylate) Nasal Spray 20-148
Lovenox (enoxaparin sodium) Injection 20-164/S-008
Nicoderm (nicotine) Transdermal 20-165/S-011
Imdur (isosorbide mononitrate) Tablets 20-225
Normiflo (ardeparin sodium) Injection 20-227
Tegretol-XR (carbamazepine) Tablets 20-234
Lescol (fluvastatin sodium) Capsules 20-261/S-012
Junior Strength Advil (ibuprofen) Tablets 20-267
Genotropin (somatropin) for Injection 20-280/S-008
Coreg (carvedilol) Tablets 20-297/S-001
Kytril (granisetron hydrochloride) Tablets 20-305
Nizoral A-D (ketoconazole) Shampoo 20-310
Agrelin (anagrelide hydrochloride) Capsules 20-333
Famvir (famciclovir) Tablets 20-363/S-012
Niaspan (niacin) Tablets 20-381
Zanaflex (tizanidine hydrochloride) Tablets 20-397
Zofran (ondansetron hydrochloride) Injection 20-403
Avita (tretinoin) Cream 20-404
Lanoxin (digoxin) Tablets 20-405
Prevacid (lansoprazole) Capsules 20-406/S-010 and S-011
Gastromark (ferumoxsil) Suspension 20-410
Genesa (arbutamine hydrochloride) Injection 20-420
Orgaran (danaparoid sodium) Injection 20-430
Pulmicort (budenoside) for Inhalation 20-441
Imodium A-D (loperamide hydrochloride) Tablets 20-448
Pandel (hydrocortisone buteprate) Cream 20-453
Galzin (zinc acetate) Capsules 20-458
Nasalcrom (cromolyn sodium) Nasal Spray 20-463
Nasacort AQ (triamcinolone acetonide) Nasal Spray 20-468/S-002
Zyflo (zileuton) Tablets 20-471
Retin-A Micro (tretinoin) Gel 20-475
Vanceril (beclomethasone dipropionate) Inhalation 20-486
Aerosol
Alphagen (brimonidine tartrate) Solution 20-490
Fareston (toremifene citrate) Tablets 20-497
Transderm Scop (scopolamine) Transdermal 20-501
Hydrochlorothiazide Capsules 20-504
Topamax (topiramate) Tablets 20-505
Aphthasol (amlexanox) Paste 20-511
Lupron Depot (leuprolide acetate) for Injection 20-517/S-002
Retrovir (zidovudine) Tablets 20-518
Loprox (ciclopirox) Gel 20-519
Condylox (podofilox) Gel 20-529
Duract (bromfenac sodium) Capsules 20-535
Norplant II (levonorgestrel) Implant 20-544
Flovent (fluticasone propionate) for Inhalation 20-549
Valtrex (valacyclovir hydrochloride) Caplets 20-550/S-003
Fosamax (alendronate sodium) Tablets 20-560/S-003
Quadramet (samarium sm-153 lexidronam pentasodium) for 20-570
Injection
Flomax (tamsulosin hydrochloride) Capsules 20-579
Cotazym (pancrelipase) Capsules 20-580
Follistim (follitropin) for Injection 20-582
Depacon (valproate sodium) Injection 20-593
Tazorac (tazarotene) Gel 20-600
Junior Strength Motrin (ibuprofen) Tablets 20-601
Zofran (ondansetron hydrochloride) Solution 20-605
Imodium (loperamide hydrochloride/simethicone) Tablets 20-606
Arthrotec (diclofenac sodium/misoprostol) Tablets 20-607
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Dovonex (calcipotriene) Solution 20-611
Pytest (C-14 urea) Capsules 20-617
Betoptic Pilo (betaxolol hydrochloride/pilocarpine 20-619
hydrochloride) Suspension
Copaxone (copolymer-1) for Injection 20-622
Anzemet (dolasetron mesylate) Tablets 20-623
Anzemet (dolasetron mesylate) Injection 20-624
Imitrex (sumatriptan) Nasal Spray 20-626
Meridia (sibutramine hydrochloride monohydrate) 20-632
Capsules
Levaquin (levofloxacin) Tablets 20-634
Levaquin (levofloxacin) Injection 20-635
Seroquel (quetiapine fumarate) Tablets 20-639
Gabitril (tiagabine hydrochloride) Tablets 20-646
Diastat (diazepam) Gel 20-648
Edex (alprostadil) for Injection 20-649
Teslascan (mangafodipir trisoodium) Injection 20-652
Alora (estradiol) Transdermal 20-655
Sporanox (itraconazole) Solution 20-657
Requip (ropinirole hydrochloride) Tablets 20-658
Butenafine Hydrochloride Cream 20-663
Dostinex (cabergoline) Tablets 20-664
Diovan (valsartan) Capsules 20-665
Mirapex (pramipexole) Tablets 20-667
Lexxel (enalapril maleate/felodipine) Tablets 20-668
Zagam (sparfloxacin) Tablets 20-677
Clinimix E Sulfite-free (amino acid with electrolytes 20-678
in dextrose with calcium) Injection
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) 20-681
Tablets
Glyset (miglitol) Tablets 20-682
Alesse (ethinyl estradiol/levonorgestrel) Tablets 20-683
Lumenhance (manganese chloride tetrahydrate) Solution 20-686
Patanol (olopatadine hydrochloride) Solution 20-688
Posicor (mibefradil dihydrochloride) Tablets 20-689
Aricept (donepezil hydrochloride) Tablets 20-690
Serevent (salmeterol xinafoate) for Inhalation 20-692
Sporanox (itraconazole) Capsules 20-694
Raxar (grepafloxacin hydrochloride) Tablets 20-695
Effexor XR (venlafaxine hydrochloride) Capsules 20-699
Muse (alprostadil) Suppository 20-700
Crinone (progesterone) Gel 20-701
Lipitor (atorvastatin calcium) Tablets 20-702
Claritin EZ (loratadine) Tablets 20-704
Rescriptor (delavirdine mesylate) Tablets 20-705
Emadine (emedastine difumarate) Solution 20-706
Skelid (tiludronate disodium) Tablets 20-707
Lupron Depot (leuprolide acetate) for Injection 20-708
Paxil (paroxetine hydrochloride) Suspension 20-710
Zyban (bupropion hydrochloride) Tablets 20-711
Carbatrol (carbamazepine) Capsules 20-712
Nicotrol (nicotine) for Inhalation 20-714
Vicoprofen (hydrocodone bitartrate/ibuprofen) Tablets 20-716
Prelay (troglitazone) Tablets 20-719
Rezulin (troglitazone) Tablets 20-720
Aldara (imiquimod) Cream 20-723
Femara (letrozole) Tablets 20-726
Uniretic (moexipril hydrochloride/hydrochlorothiazide) 20-729
Tablets
Clinimix Sulfite-free (amino acid in dextrose) 20-734
Injection
Teveten (eprosartan mesylate) Tablets 20-738
Baycol (cerivastatin) Tablets 20-740
BSS (balanced salt) Solution 20-742
Noritate (metronidazole) Cream 20-743
Tilade (nedocromil sodium) Inhalation Solution 20-750
Crinone (progesterone) Gel 20-756
Avapro (irbesartan) Tablets 20-757
Irbesartan/hydrochlorthiazide Tablets 20-758
Trovan (trovafloxacin mesylate) Tablets 20-759
Trovan (alatrovafloxacin mesylate) Injection 20-760
Nasonex (mometasone furoate) Nasal Spray 20-762
Propulsid Quicksolv (cisapride) Tablets 20-767
Zomig (zolmitriptan) Tablets 20-768
Viracept (nelfinavir mesylate) for Solution 20-778
Viracept (nelfinavir mesylate) Tablets 20-779
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Cipro (ciprofloxacin) for Suspension 20-780
Allegra-D (fexofenadine hydrochloride/pseudoephedrine 20-786
hydrochloride) Tablets
Cardizem (diltiazem hydrochloride) for Injection 20-792
Floxin (ofloxacin) Solution 20-799
Fortovase (saquinavir) Capsules 20-828
Prograf (tacrolimus) Capsules 50-708
Prograf (tacrolimus) Capsules 50-708/S-008
Helidac (bismuth subsalicylate tablets, metronidazole 50-719
tablets, and tetracycline hydrochloride capsules)
Cellcept (mycophenolate mofetil) Tablets 50-723
Amphotec (amphotericin B) Cholesteryl Sulfate for 50-729
Injection
Zithromax (azithromycin) for Injection 50-733
Idamycin-PFS (idarubicin hydrochloride) Injection 50-734
Neoral (cyclosporine) Capsules 50-735
Neoral (cyclosporine) Solution 50-736
Neoral (cyclosporine) Capsules 50-737
Neoral (cyclosporine) Solution 50-738
Omnicef (cefdinar) Capsules 50-739
Ambisome (amphotericin B) Liposome for Injection 50-740
Stromectol (ivermectin) Tablets 50-742
Bactroban (mupirocin calcium) Cream 50-746
Omnicef (cefdinir) Suspension 50-749
Primsol (trimethoprim hydrochloride) Solution 74-374/S-002
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As part of its review of each of the NDA's and supplements listed
in this table, FDA reviewed an EA. In each instance, FDA found that the
approval of the NDA or supplement will not significantly affect the
human environment. In accordance with the Council on Environmental
Quality regulations in 40 CFR 1501.4(e) and FDA regulations in
Sec. 25.41, FDA prepared a FONSI for each NDA and supplement. This
notice announces that the EA's and FONSI's for these human drug
products may be seen in the Dockets Management Branch (address above)
between 9 a.m. and 4 p.m., Monday through Friday. For a fee, copies of
these EA's and FONSI's may be obtained by writing the Freedom of
Information Staff (address above). The request should identify by the
application number the EA's and FONSI's requested. Separate requests
should be submitted for each application number. Additional information
regarding the submission of freedom of information requests is
available on the Internet at http://www.fda.gov/opacom/backgrounders/
foiahand.html.
Dated: May 7, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-13045 Filed 5-15-98; 8:45 am]
BILLING CODE 4160-01-F