Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Notices 11107

AADA No. Drug Applicant

60–128 Ampicillin Trihydrate ........................................................... IBI, Giovanni Lorenzini S.p.A., 20139 Milano, Italy.

60–130 Ampicillin ............................................................................ Do.

61–659 Erythromycin Delayed-Release Tablets, U.S.P., 250 milligrams (mg) ..................................................................... Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta,

GA 30062.

61–818 Cephalexin Monohydrate ................................................... IBI.

61–923 Amoxicillin Trihydrate ......................................................... Do.

62–052 Nystatin Ointment, U.S.P. .................................................. Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960.

62–430 Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, U.S.P. ................................................................... Pharmafair, Inc., 110 Kennedy Dr., Hauppauge, NY

11788.

62–449 Cephalothin Sodium ........................................................... IBI.

62–666 Cephalothin Sodium for Injection, U.S.P., 1 gram (g) and

2 g ................................................................................... Fujisawa USA, Inc., Parkway North Center, Three Parkway North, Deerfield, IL 60015–2548

62–710 Cephalothin Sodium ........................................................... IBI.

62–747 Clindamycin Phosphate Injection, U.S.P., 150 mg/milliliters (mL) ........................................................................ Fujusawa USA, Inc.

ANDA No. Drug Applicant

80–041 Trisulfapyrimidines Oral Suspension, U.S.P., 0.5 g/5 mL .. Solvay Pharmaceuticals, Inc.

80–921 Vitamin A Capsules, U.S.P., 50,000 units ......................... Lemmon Co.

83–993 Phendimetrazine Tartrate Tablets, U.S.P., 35 mg ............. Solvay Pharmaceuticals, Inc.

84–435 Meprobamate Tablets, U.S.P., 200 mg .............................. Do.

85–897 Phendimetrazine Tartrate Capsules, U.S.P., 35 mg .......... Do.

87–074 Diatrizoate Meglumine and Diatriozoate Sodium Injectin,

U.S.P. .............................................................................. Mallinckrodt Medical, Inc., P.O. Box 5840, St. Louis, MO

63134.

87–113 Triamcinolone Acetonide Cream, U.S.P. 0.1% .................. Solvay Pharmaceuticals, Inc.

87–210 Reserpine, Hydralazine Hydrochloride, and

Hydrochlorothiazide Tablets, U.S.P., 0.1 mg/25 mg/15

mg ................................................................................... Do.

87–833 Prednisone Tablets, U.S.P., 25 mg .................................... Roxane Laboratories, Inc., P.O. Box 16532, Columbus,

OH 43216–6532

88–071 Dexamethasone Sodium Phosphate Ophthalmic Ointment, U.S.P., 0.05% ....................................................... Pharmafair, Inc.

88–612 Phentermine Hydrochloride Capsules, U.S.P., 30 mg ....... Lemmon Co.

Therefore, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(e)) and under authority

delegated to the Director, Center for

Drug Evaluation and Research (21 CFR

5.82), approval of the applications listed

above, and all amendments and

supplements thereto, is hereby

withdrawn, effective March 31, 1995.

Dated: February 16, 1995.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 95–5060 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0050]

Drug Export; Sandostatin (Octreotide

Acetate) Lar Injection; 10-Milligram

(mg), 20-mg, and 30-mg Vials

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Sandoz Pharmaceuticals Corp. has

filed an application requesting

conditional approval for the export of

the human drug Sandostatin (octreotide

acetate) LAR Injection 10-mg, 20-mg,

and 30-mg vials to Switzerland for

further packaging and marketing.

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

human drugs under the Drug Export

Amendments Act of 1986 should also be

directed to the contact person.

FOR FURTHER INFORMATION CONTACT:

James E. Hamilton, Center for Drug

Evaluation and Research (HFD–310),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–2073.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of drugs that are not currently

approved in the United States. Section

802(b)(3)(B) of the act sets forth the

requirements that must be met in an

application for approval. Section

802(b)(3)(C) of the act requires that the

agency review the application within 30

days of its filing to determine whether

the requirements of section 802(b)(3)(B)

have been satisfied. Section 802(b)(3)(A)

of the act requires that the agency

publish a notice in the Federal Register

within 10 days of the filing of an

application for export to facilitate public

participation in its review of the

application. To meet this requirement,

the agency is providing notice that

Sandoz Pharmaceuticals Corp., 59 Route

10, East Hanover, NJ 07936–1080, has

filed an application requesting approval

for the export of the human drug

Sandostatin (octreotide acetate) LAR

Injection 10-mg, 20-mg, and 30-mg vials

to Switzerland. This product is a new

formulation of octreotide acetate

manufactured by a different process

which is indicated for aromegaly,

malignant carcinoid syndrome, and

vipoma. The firm does have approval

for Sandostatin Injection. The
11108 Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Notices

application was received and filed in

the Center for Drug Evaluation and

Research on December 27, 1994, which

shall be considered the filing date for

purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by March 13,

1995, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Drug

Evaluation and Research (21 CFR 5.44).

Dated: February 9, 1995.

Edward Miracco,

Acting Deputy Director, Office of Compliance,

Center for Drug Evaluation and Research.

[FR Doc. 95–5059 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0049]

Drug Export; Zyloprim (Allopurinol

Sodium) for Injection Equivalent to 500

Milligrams Allopurinol Sterile

Lyophilized Powder

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Burroughs Wellcome Co. has filed

an application requesting approval for

the export of the human drug Zyloprim

(allopurinol sodium) for Injection

equivalent to 500 milligrams (mg)

allopurinol to Canada.

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

human drugs under the Drug Export

Amendments Act of 1986 should also be

directed to the contact person.

FOR FURTHER INFORMATION CONTACT:

James E. Hamilton, Center for Drug

Evaluation and Research (HFD–310),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–2073.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of drugs that are not currently

approved in the United States. Section

802(b)(3)(B) of the act sets forth the

requirements that must be met in an

application for approval. Section

802(b)(3)(C) of the act requires that the

agency review the application within 30

days of its filing to determine whether

the requirements of section 802(b)(3)(B)

have been satisfied. Section 802(b)(3)(A)

of the act requires that the agency

publish a notice in the Federal Register

within 10 days of the filing of an

application for export to facilitate public

participation in its review of the

application. To meet this requirement,

the agency is providing notice that

Burroughs Wellcome Co., 3030

Cornwallis Rd., P.O. Box 12700,

Research Triangle Park, NC 27709–2700,

has filed an application requesting

approval for the export of the human

drug Zyloprim (allopurinol sodium) for

Injection equivalent to 500 mg

allopurinol to Canada. This product is

primarily indicated for its prophylactic

usage in patients with leukemia,

lymphomas, or other malignancies,

receiving antineoplastic treatment

(radiation or cytotoxic drugs) which

might induce increased uric acid levels.

The firm does have new drug

application approval for Zyloprim

(allopurinol) Tablets in two dosage

strengths. The application was received

and filed in the Center for Drug

Evaluation and Research on January 25,

1995, which shall be considered the

filing date for purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by March 13,

1995, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Drug

Evaluation and Research (21 CFR 5.44).

Dated: February 8, 1995.

Edward Miracco,

Acting Deputy Director, Office of Compliance,

Center for Drug Evaluation and Research.

[FR Doc. 95–5062 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[NM–070–5101–G014; NMNM93652]

Notice of intent, and Notice of Scoping

Meetings and Comment Period; New

Mexico

AGENCY: Bureau of Land Management,

Interior.

ACTION: Notice of intent, and notice of

scoping meetings with a public

comment period.

SUMMARY: In accordance with the

National Environmental Policy Act, the

Bureau of Land Management is directing

the preparation of an environmental

document for the construction,

operation, and maintenance of a

pipeline that would be 12 or 16 inches

in diameter and approximately 400

miles in length. The proposed project is

known as the Mid-American Pipeline

Company Four Corners Loop Project.

The environmental document is being

prepared as an environmental

assessment, but will be advanced to the

environmental impact statement level if

this is indicated by scoping or by a

determination of significant impacts in

the environmental assessment. Public

meetings will be held for the proposed

pipeline project with a public comment

period.

DATES: Public scoping meetings are

planned in Albuquerque, New Mexico

at the Albuquerque Convention Center,

San Miguel Room, 401 Second Street,

NW., on March 15, 1995 at 3:00 p.m. to

9:00 p.m. and in Roswell, New Mexico

at the Roswell Inn, Berrendo Room,

1815 North Main at 3:00 p.m. to 9:00

p.m. on March 16, 1995, respectively.

The meeting agenda will be to conduct

an open-house to receive interested

parties from 3:00 p.m. to 5:30 p.m. with

a formal presentation starting at 7:00

p.m., followed by a workshop to receive

comments, and ending at 9:00 p.m.