Federal Register / Vol. 61, No. 99 / Tuesday, May 21, 1996 / Notices 25497

Dated: May 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–12650 Filed 5–20–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95P–0285]

Determination That Glyburide Tablets

4.5 Milligrams Was Not Withdrawn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) has determined

that glyburide (Glynase PresTab)

tablets 4.5 milligrams (mg) was not

withdrawn from sale for reasons of

safety or effectiveness. This

determination will allow sponsors to

submit abbreviated new drug

applications (ANDA’s) for glyburide

tablets 4.5 mg.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1049.

SUPPLEMENTARY INFORMATION: In 1984,

Congress passed into law the Drug Price

Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

(the 1984 amendments), 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 included what

is now section 505(j)(6) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 355(j)(6)), 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drugs are withdrawn from the list if the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withdrawn from sale for reasons of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 (§ 314.162 (21

CFR 314.162)). Another FDA regulation

also provides 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.

Novopharm Ltd., submitted a citizen

petition, dated August 21, 1995 (Docket

No. 95P–0285/CP1), under 21 CFR

10.25(a) and 10.30 requesting that the

agency determine whether glyburide

tablets 4.5 mg was withdrawn from sale

for reasons of safety or effectiveness

and, if the agency determines that the

drug was not withdrawn from sale for

reasons of safety or effectiveness, to

keep the drug in the ‘‘Approved Drug

Products with Therapeutic Equivalence

Evaluations.’’ Glyburide tablets 4.5 mg,

along with the 1.5-mg, 3-mg, and 6-mg

strengths, is the subject of approved

NDA 20–051 held by the Upjohn Co.

(Upjohn). Upjohn obtained approval to

market the 4.5-mg strength of glyburide

tablets on September 24, 1993. Upjohn

has never marketed the 4.5-mg strength

of glyburide tablets. FDA has

determined, for purposes of §§ 314.161

and 314.162(c), that never marketing an

approved drug product is equivalent to

withdrawing the drug for sale.

FDA has reviewed its records and,

under §§ 314.161 and 314.162(c), has

determined that glyburide tablets 4.5 mg

was not withdrawn from sale for reasons

of safety or effectiveness and will

continue to list glyburide tablets 4.5 mg

in the ‘‘Discontinued Drug Product List’’

contained in the ‘‘Approved Drug

Products with Therapeutic Equivalence

Evaluations.’’ The ‘‘Discontinued Drug

Product List’’ lists, among other items,

drug products that have been

discontinued from marketing for reasons

other than safety or effectiveness.

ANDA’s that refer to glyburide tablets

4.5 mg may be submitted to the agency.

The agency notes that there is a patent

listed in the Orange Book for Glynase

PresTab tablets that will not expire

until April 10, 2007. This patent will

prevent FDA from approving ANDA’s

that refer to Glynase PresTab tablets

with an effective date before April 10,

2007, if the patent is valid and the

manufacture, use, or sale of the drug

product for which approval is being

sought would infringe the patent.

Novopharm Ltd., states in its petition

that it does not intend to make a generic

drug that refers to Glynase PresTab

tablets available for sale until the

expiration of the patent. Between now

and the time an ANDA for glyburide

tablets 4.5 mg is submitted, approved, or

the approval goes into effect, FDA may

obtain new information on the safety

and effectiveness of glyburide tablets

that will prevent the agency from

receiving or approving the ANDA.

Dated: May 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–12759 Filed 5–20–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95P–0128]

Determination That Hydrocortisone

Acetate Topical Ointment 2.5% 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) has determined

that hydrocortisone (Cortef) acetate

topical ointment 2.5% was not

withdrawn from sale for reasons of

safety or effectiveness. This

determination will allow sponsors to

submit abbreviated new drug

applications (ANDA’s) for

hydrocortisone acetate topical ointment

2.5%.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1049.

SUPPLEMENTARY INFORMATION: In 1984,

Congress passed into law the Drug Price

Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

(the 1984 amendments), 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
25498 Federal Register / Vol. 61, No. 99 / Tuesday, May 21, 1996 / Notices

subject of the ANDA is bioequivalent to

the listed drug.

The 1984 amendments included what

is now section 505(j)(6) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 355(j)(6)), 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 (§ 314.162 (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.

On May 12, 1995, Reed & Carnrick

Pharmaceuticals submitted a citizen

petition (Docket No. 95P–0128/CP1)

under 21 CFR 10.25(a) and 10.30

requesting that the agency determine

whether hydrocortisone acetate topical

ointment 2.5% was withdrawn from

sale for reasons of safety or effectiveness

and, if the agency determines that the

drug was not withdrawn from sale for

reasons of safety or effectiveness, to

keep the drug in the ‘‘Approved Drug

Products with Therapeutic Equivalence

Evaluations.’’ Hydrocortisone acetate

topical ointment 2.5%, along with the

1% strength, is the subject of approved

NDA 8–917 held by the Upjohn Co.

(Upjohn). On July 28, 1953, Upjohn

obtained approval to market the 2.5%

strength of hydrocortisone acetate

topical ointment. Upjohn withdrew the

drug from sale in 1991.

FDA has reviewed its records and,

under §§ 314.161 and 314.162(c), has

determined that hydrocortisone acetate

topical ointment 2.5% was not

withdrawn from sale for reasons of

safety or effectiveness and will continue

to list hydrocortisone acetate topical

ointment 2.5% in the ‘‘Discontinued

Drug Product List’’ contained in the

‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations.’’

The ‘‘Discontinued Drug Product List’’

lists, among other items, drug products

that have been discontinued from

marketing for reasons other than safety

or effectiveness. ANDA’s that refer to

hydrocortisone acetate topical ointment

2.5% may be submitted to the agency.

Dated: May 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–12690 Filed 5–20–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 93P–0322]

Determination that

Medroxyprogesterone Acetate 100

Milligrams per Milliliter 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) has determined

that medroxyprogesterone acetate

(Depo-Provera) 100 milligrams per

milliliter (mg/mL) was not withdrawn

from sale for reasons of safety or

effectiveness. This determination will

allow sponsors to submit abbreviated

new drug applications (ANDA’s) for

medroxyprogesterone acetate 100 mg/

mL.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1049.

SUPPLEMENTARY INFORMATION: In 1984,

Congress passed into law the Drug Price

Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

(the 1984 amendments), 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 included what

is now section 505(j)(6) of the Federal

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

355(j)(6)), 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 (§ 314.162 (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.

On August 30, 1993, King & Spalding

submitted a citizen petition (Docket No.

93P–0322/CP1) under 21 CFR 10.25(a)

and 10.30 requesting that the agency

determine whether

medroxyprogesterone acetate 100 mg/

mL was withdrawn from sale for reasons

of safety or effectiveness and, if the

agency determines that the drug was not

withdrawn from sale for reasons of

safety or effectiveness, to keep the drug

in the ‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations.’’

Medroxyprogesterone acetate 100 mg/

mL, along with the 400 mg/mL strength,

is the subject of approved NDA 12–541

held by the Upjohn Co. (Upjohn). On

December 1, 1992, Upjohn withdrew

medroxyprogesterone acetate 100 mg/

mL from sale.

FDA has reviewed its records and,

under §§ 314.161 and 314.162(c), has

determined that medroxyprogesterone

acetate 100 mg/mL was not withdrawn

from sale for reasons of safety or

effectiveness and will continue to list

medroxyprogesterone acetate 100 mg/

mL in the ‘‘Discontinued Drug Product

List’’ contained in the ‘‘Approved Drug

Products with Therapeutic Equivalence

Evaluations.’’ The ‘‘Discontinued Drug

Product List’’ lists, among other items,

drug products that have been

discontinued from marketing for reasons

other than safety or effectiveness.

ANDA’s that refer to

medroxyprogesterone acetate 100 mg/

mL may be submitted to the agency.

FDA has also considered the comment

submitted by Upjohn, dated November

19, 1993, opposing an FDA

determination that

medroxyprogesterone acetate 100 mg/

mL was withdrawn from the market for

reasons other than safety or

effectiveness. The comment does not

contain any information indicating that

the drug was withdrawn for reasons of

safety or effectiveness, but rather

indicates that Upjohn did not perceive

a need to keep medroxyprogesterone