Federal Register / Vol. 65, No. 120 / Wednesday, June 21, 2000 / Notices 38561

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW,

Washington, DC 20503, Attn: Desk

Officer for ACF.

Dated: June 15, 2000.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 00–15547 Filed 6–20–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P–0842]

Determination That Ranitidine

Effervescent 75–Milligram Tablet Was

Not Withdrawn From Sale for Reasons

of Safety or Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

determination that ranitidine

effervescent 75-milligram (mg) tablet

(Zantac Efferdose) was not withdrawn

from sale for reasons of safety or

effectiveness. This determination will

allow FDA to approve abbreviated new

drug applications (ANDA’s) for

ranitidine effervescent 75-mg tablet.

FOR FURTHER INFORMATION CONTACT:

Andrea C. Masciale, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In 1984,

Congress enacted the Drug Price

Competition and Patent Term

Restoration Act of 1984 (the 1984

amendments) (Public Law 98–417),

which authorized the approval of

duplicate versions of drug products

approved under an ANDA procedure.

ANDA sponsors must, with certain

exceptions, show that the drug for

which they are seeking approval

contains the same active ingredient in

the same strength and dosage form as

the ‘‘listed drug,’’ which is a version of

the drug that was previously approved

under a new drug application (NDA).

Sponsors of ANDA’s do not have to

repeat the extensive clinical testing

otherwise necessary to gain approval of

an NDA. The only clinical data required

in an ANDA are data to show that the

drug that is the subject of the ANDA is

bioequivalent to the listed drug.

The 1984 amendments include what

is now section 505(j)(7) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

355(j)(7)), which requires FDA to

publish a list of all approved drugs.

FDA publishes this list as part of the

‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations,’’

which is generally known as the

‘‘Orange Book.’’ Under FDA regulations,

drugs are withdrawn from the list if the

agency withdraws or suspends approval

of the drug’s NDA or ANDA for reasons

of safety or effectiveness or if FDA

determines that the listed drug was

withdrawn from sale for reasons of

safety or effectiveness (21 CFR 314.162).

Regulations also provide that the agency

must make a determination as to

whether a listed drug was withdrawn

from sale for reasons of safety or

effectiveness before an ANDA that refers

to that listed drug may be approved

(§ 314.161(a)(1) (21 CFR 314.161(a)(1))).

FDA may not approve an ANDA that

does not refer to a listed drug.

Ranitidine effervescent 75-mg tablet is

the subject of NDA 20–745. FDA

approved NDA 20–745, held by Glaxo

Wellcome, Inc. (Glaxo), on February 26,

1998. Glaxo never marketed the

ranitidine effervescent 75-mg tablet.

Glaxo transferred ownership of NDA

20–745 to the Warner-Lambert Co.

(Warner-Lambert) effective January 1,

1999. To date, Warner-Lambert has not

marketed the ranitidine effervescent 75-

mg tablet.

On March 1, 2000, Thomas Blake,

R.Ph., submitted a citizen petition

(Docket No. 00P–0842/CP1) under 21

CFR 10.30 to FDA. The petition

requested that the agency determine

whether ranitidine effervescent 75-mg

tablet was withdrawn from sale for

reasons of safety or effectiveness. FDA

has determined that, for the purposes of

§ 314.161, never marketing an approved

drug product is equivalent to

withdrawing the drug product from sale.

FDA has reviewed its records and,

under § 314.161, has determined that

the decision by Glaxo and WarnerLambert not to market ranitidine

effervescent 75-mg tablet was not for

reasons of safety or effectiveness.

Accordingly, the agency will maintain

ranitidine effervescent 75-mg tablet in

the ‘‘Discontinued Drug Product List’’

section of the Orange Book. The

‘‘Discontinued Drug Product List’’

delineates, among other items, drug

products that have been discontinued

from marketing for reasons other than

safety or effectiveness. ANDA’s that

refer to ranitidine effervescent 75-mg

tablet may be approved by the agency.

Dated: June 14, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–15555 Filed 6–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P–0585]

Determination That Fluoxetine

Hydrochloride 20–Milligram Tablets

Were Not Withdrawn From Sale for

Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

determination that fluoxetine

hydrochloride 20-milligram (mg) tablets

(Prozac) were not withdrawn from sale

for reasons of safety or effectiveness.

This determination will allow FDA to

approve abbreviated new drug

applications (ANDA’s) for fluoxetine

hydrochloride 20-mg tablets.

FOR FURTHER INFORMATION CONTACT:

Carol E. Drew, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In 1984,

Congress enacted the Drug Price

Competition and Patent Term

Restoration Act of 1984 (the 1984

amendments) (Public Law 98–417),

which authorized the approval of

duplicate versions of drug products

approved under an ANDA procedure.

ANDA sponsors must, with certain

exceptions, show that the drug for

which they are seeking approval

contains the same active ingredient in

the same strength and dosage form as

the ‘‘listed drug,’’ which is a version of

the drug that was previously approved

under a new drug application (NDA).

Sponsors of ANDA’s do not have to

repeat the extensive clinical testing

otherwise necessary to gain approval of

an NDA. The only clinical data required

in an ANDA are data to show that the

drug that is the subject of the ANDA is

bioequivalent to the listed drug.

The 1984 amendments include what

is now section 505(j)(7) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

355(j)(7)), which requires FDA to

publish a list of all approved drugs.

FDA publishes this list as part of the

‘‘Approved Drug Products With