[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)]
[Notices]
[Pages 22960-22962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10911]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0138]
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 141 new drug applications
(NDA's), abbreviated new drug applications (ANDA'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, 301-594-5721.
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 25.41(b).)
FDA implements NEPA through its regulations in part 25 (21 CFR part
25). Under those regulations, actions to approve NDA's, ANDA's, and
supplements to existing approvals ordinarily require the preparation of
an EA. (See Sec. 25.22(a)(8) and (a)(14).)
FDA approved 141 NDA's, ANDA's, and supplemental NDA's for the
products listed in the following table:
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Drug Application Number
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Coumadin (warfarin sodium) for Injection.. 09-218/S-077 and S-078
Tavist-1 (clemastine fumarate) Tablets.... 17-661/S-048
Tavist-D (clemastine fumarate/ 18-298/S-024
phenylpropanolamine hydrochloride)
Tablets.
Eulexin (flutamide) Capsules.............. 18-554/S-014
Nicorette (nicotine) Chewing Gum.......... 18-612/S-022, 20-066/S-004
Depakote (divalproex sodium) Tablets...... 18-723/S-020
Calcijex (calcitriol) Injection........... 18-874/S-007
Etodolac (lodine) Capsules................ 18-922/S-013
Heparin Sodium in 5% Dextrose I.V. 19-339/S-011, S-012, S-013,
Infusion. and S-014
Prinivil (lisinopril) Tablets............. 19-558/S-027
Depakote (divalproex sodium) Sprinkle 19-680/S-008
Capsules.
Saizen (somatropin) for Injection......... 19-764
Zestril (lisinopril) Tablets.............. 19-777/S-023
Nasacort (triamcinolone acetonide) 19-798/S-006
Inhalation Aerosol.
Prilosec (omeprazole) Capsules............ 19-810/S-033 and S-037
Pro-amatine (midodrine hydrochloride) 19-815
Tablets.
Renova (tretinoin) Cream.................. 19-963
Aredia (pamidronate disodium) for 20-036/S-011
Injection.
Lioresal (baclofen) Injection............. 20-075/S-004
Imitrex (sumatriptan succinate) Injection. 20-080/S-004
Zofran (ondansetron hydrochloride) Tablets 20-103/S-004
Acthrel (corticorelin ovine triflutate) 20-162
for Injection.
Nilandron (nilutamide) Tablets............ 20-169
Elmiron (pentosan polysulfate sodium) 20-193
Capsules.
Zinecard (dexrazoxane) for Injection...... 20-212
Ethyol (amifostine) for Injection......... 20-221 and 20-221/S-002
Luvox (fluvoxamine maleate) Tablets....... 20-243/S-004
[[Page 22961]]
Intralipid (fat emulsion) I.V. Infusion... 20-248
Voltaren XR (diclofenac sodium) Tablets... 20-254
Monpril HCT (fosinopril sodium/ 20-286
hydrochlorthiazide) Tablets.
Zyloprim (allopurinol sodium) for 20-298
Injection.
Fludeoxyglucose F-18 Injection............ 20-306
Oxilan (ioxilan) Injection................ 20-316
Zyrtec (cetirizine hydrochloride) Syrup.. 20-346
Visipaque (iodixanol) Injection.......... 20-351
Wellbutrin (bupropion hydrochloride) 20-358
Tablets.
Myoview (technetium TC99M tetrofosmin) 20-372
Injection.
Cordarone (amiodarone hydrochloride) 20-377
Injection.
Nicotrol (nicotine) Nasal Spray.......... 20-385
Tiazac (diltiazem hydrochloride) Capsules 20-401
Zerit (stavudine) Oral Solution.......... 20-413
Remeron (mirtazapine) Tablets............ 20-415
Feridex (ferumoxides) Injection.......... 20-416
Femstat (butoconazole nitrate) Vaginal 20-421
Cream.
Azelex (azelaic acid) Cream.............. 20-428
Vesanoid (tretinoin) Capsules............ 20-438
Timolol Ophthalmic Solution.............. 20-439
Flolan (epoprostenol sodium) for 20-444
Injection.
Cerebyx (fosphenytoin sodium) Injection.. 20-450
Cytovene (ganciclovir) Capsules.......... 20-460/S-005
Azulfidine (sulfasalazine) Tablets....... 20-465
Nasacort AQ (triamcinolone acetonide) 20-468
Nasal Spray.
Claritin-D (loratadine/pseudoephedrine 20-470
sulfate) Tablets.
Tagamet HB (cimetidine hydrochloride) 20-473
Tablets.
Ultane (sevoflurane) Inhalation.......... 20-478
Valtrex (valacyclovir hydrochloride) 20-487
Caplets.
Corvert (ibutilide fumarate) Injection... 20-491
Amaryl (glimepriride) Tablets............ 20-496
Actron (ketoprofen) Tablets/Caplets...... 20-499
Proventil HFA (albuterol sulfate) 20-503
Inhalation Aerosol.
Tiamate (diltiazem malate) Tablets....... 20-506
Teczem (diltiazem malate/enalapril 20-507
maleate) Tablets.
Lac-Hydrin (ammonium lactate) Cream...... 20-508
Gemzar (gemcitabine hydrochloride) 20-509
Injection.
Zantac (ranitidine hydrochloride) Tablets 20-520
Mentax (butenafine hydrochloride) Cream.. 20-524
Gyne-Lotrimin 3 (clotimazole) Vaginal 20-525
Inserts.
Conjugated estrogens/Medroxyprogesterone 20-527
acetate Tablets.
Mavik (trandolapril) Tablets............. 20-528
Iontocaine (lidocaine/epinephrine) 20-530
Topical Solution.
Metrocream (metronidazole) Cream......... 20-531
Ivy-Block (quaternium-18 bentonite) 20-532
Lotion.
Naropin (ropivacaine hydrochloride) 20-533
Injection.
Nicotrol (nicotine) Transdermal System... 20-536
Arimidex (anastrozole) Tablets........... 20-541
Dopamine hydrochloride in 5% Dextrose 20-542
Injection.
Accolate (zafirlukast) Tablets........... 20-547
Flovent (fluticasone propionate) 20-548
Inhalation Aerosol.
Nimbex (cisatracurium besylate) Injection 20-551
Oxycontin (oxycodone hydrochloride) 20-553
Tablets.
Dovonex (calcipotriene) Cream............ 20-554
Axid AR (nizatidine) Tablets............. 20-555
Tritec (ranitidine bismuth citrate) 20-559
Tablets.
Humalog (insulin lispro) Injection....... 20-563
Epivir (lamivudine) Tablets.............. 20-564
Vitrasert (ganciclovir) Implant.......... 20-569
Camptosar (irinotecan hydrochloride) 20-571
Injection.
Buphenyl (phenylbutyrate sodium) Tablets. 20-572
Buphenyl (phenylbutyrate sodium) Oral 20-573
Powder.
Lidocaine Transoral Delivery System...... 20-575
Cystadane (betaine) Oral Powder.......... 20-576
Elliotts B Solution...................... 20-577
Zoladex (goserelin acetate) Implant...... 20-578
Lodine (etodolac) Tablets................ 20-584
Risperdal (risperidone) Oral Solution.... 20-588
Children's Advil (ibuprofen) Oral 20-589
Suspension.
Tarka (trandolapril/verapamil 20-591
hydrochloride) Tablets.
Zyprexa (olanzapine) Tablets............. 20-592
Epivir (lamivudine) Oral Solution........ 20-596
Xalatan (latanoprost) Ophthalmic Solution 20-597
Rilutek (riluzole) Tablets............... 20-599
Jr. Strength Motrin (ibuprofen) Caplets.. 20-602
Children's Motrin (ibuprofen) Oral Drops. 20-603
Serostim (somatropin) for Injection...... 20-604
Alphagan (brimonidine tartrate) 20-613
Ophthalmic Solution.
Clonidine hydrochloride Injection........ 20-615
Kadian (morphine sulfate) Capsules....... 20-616
Allegra (fexofenadine hydrochloride) 20-625
Capsules.
Invirase (saquinavir) Capsules........... 20-628
Denavir (penciclovir) Cream.............. 20-629
[[Page 22962]]
Ultiva (remifentanil hydrochloride) 20-630
Injection.
Morphine Sulfate Injection............... 20-631
Viramune (nevirapine) Tablets............ 20-636
Gliadel Wafer (polifeprosan 20 with 20-637
carmustine) Implant.
Tavist-D (clemastine fumerate/ 20-640
phenylpropanolamine hydrochloride)
Tablets.
Claritin (loratadine) Syrup.............. 20-641
Eldepryl (selegiline hydrochloride) 20-647
Capsules.
Norvir (ritonavir) Oral Solution......... 20-659
Albenza (albendazole) Tablets............ 20-666
Hycamtin (topotecan hydrochloride) 20-671
Injection.
Norvir (ritonavir) Capsules.............. 20-680
Crixivan (indinavir sulfate) Capsules.... 20-685
Dexferrum (iron dextran) Injection....... 40-024
Blenoxane (bleomycin sulfate) for 50-443/S-025
Injection.
Maxipime (cefepime hydrochloride) for 50-679
Injection.
Daunoxome (liposomal daunorubicin) 50-704
Injection.
Merrem (meropenem) Injection............. 50-706
Doxil (liposomal doxorubicin) Injection.. 50-718
Augmentin (amoxicillin/clavulanic acid) 50-720
Tablet.
Biaxin (clarithromycin) Tablets.......... 50-721
Abelcet (amphotericin B lipid complex) 50-724/S-002
Injection.
Augmentin (amoxicillin/clavulanate 50-725
potassium) Oral Suspension.
Augmentin (amoxicillin/clavulanate 50-726
potassium) Tablets.
Zithromax (azithromycin) Tablets......... 50-730
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As part of its review of each of the NDA's, ANDA's, and supplements
listed in this table, FDA reviewed an EA. In each instance, FDA found
that the approval of the NDA, ANDA, 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. 25.32, FDA prepared a FONSI for each NDA, ANDA,
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. For
additional information regarding the submission of freedom of
information requests, call 301-443-6310.
Dated: April 21, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-10911 Filed 4-25-97; 8:45 am]
BILLING CODE 4160-01-F
