7976 Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Notices

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

Angelini Pharmaceuticals, Inc., 70

Grand Ave., River Edge, NJ 07661, has

filed an application requesting approval

for the export of the human drug

Remydrial two component system

containing Dapiprazole Hydrochloride

50 mg in 260 mg Lyophilized powder

and solvent containing 1.0 mg

Benzalkonium Chloride in 10 mL bottle

to Germany. The firm currently holds an

approved new drug application for this

product, however, this preparation

contains modifications which consists

of a formulation change in the solvent

for isotonicity, a change in the package

size and design for ease of use, and a

change in the manufacturer. This

product is used for the reversal of

medicine-induced pupil dilation. The

application was received and filed in

the Center for Drug Evaluation and

Research on November 22, 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 February 21,

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: January 31, 1995.

Kathy P. Miracco,

Acting Director, Office of Compliance, Center

for Drug Evaluation and Research.

[FR Doc. 95–3440 Filed 2–9–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0031]

Drug Export; Valacyclovir

Hydrochloride Bulk Drug Substance

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 conditional

approval for the export of the bulk drug

substance valacyclovir hydrochloride to

the United Kingdom.

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., Research Triangle Park,

NC 27709, has filed an application

requesting conditional approval for the

export of the bulk drug substance

valacyclovir hydrochloride to the

United Kingdom. The product is

indicated for the treatment of herpes

zoster (shingles). The application was

received and filed in the Center for Drug

Evaluation and Research on October 13,

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 February 21,

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: January 31, 1995.

Kathy P. Miracco,

Acting Director, Office of Compliance, Center

for Drug Evaluation and Research.

[FR Doc. 95–3442 Filed 2–9–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0032]

Drug Export; VisipaqueTM (Iodixanol)

Injection 270 Milligrams Iodixanol/

Milliliter (mg I/mL) and 320 mg I/mL

Supplied in 50 mL Vial, 100 mL, 150

mL, and 200 mL Bottle

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Nycomed, Inc., has filed an

application requesting approval for the

export of the human drug VisipaqueTM

(iodixanol) Injection 270 milligrams

iodixanol/milliliter (mg I/mL) and 320

mg I/mL supplied in 50 mL vial, 100

mL, 150 mL, and 200 mL bottle 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