38562 Federal Register / Vol. 65, No. 120 / Wednesday, June 21, 2000 / Notices

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drugs are withdrawn from the list if the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withdrawn from sale for reasons of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drug was withdrawn from sale for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 February 11, 2000, Lachman

Consultant Services, Inc., submitted a

citizen petition (Docket No. 00P–0585/

CP1) under 21 CFR 10.30 to FDA. The

petition requested that the agency

determine whether fluoxetine

hydrochloride 20-mg tablets were

withdrawn from sale for reasons of

safety or effectiveness. Fluoxetine

hydrochloride 20-mg tablets are the

subject of NDA 20–974. FDA approved

NDA 20–974, held by Eli Lilly and Co.,

on March 9, 1999. On April 2, 1999, Eli

Lilly and Co. informed FDA that it had

decided not to market fluoxetine

hydrochloride 20-mg tablets. FDA has

determined that, for purposes of

§§ 314.161 and 314.162, never

marketing an approved drug product is

equivalent to withdrawing the drug

from sale.

FDA has reviewed its records and,

under § 314.161, has determined that Eli

Lilly and Co.’s decision not to market

fluoxetine hydrochloride 20-mg tablets

was not for reasons of safety or

effectiveness. Accordingly, the agency

will continue to list fluoxetine

hydrochloride 20-mg tablets 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 fluoxetine hydrochloride 20-mg

tablets may be approved by the agency.

Dated: June 14, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–15556 Filed 6–20–00; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P–0090]

Determination That Paroxetine

Hydrochloride 10-, 20-, 30-, and 40-

Milligram Capsules 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) has determined

that paroxetine hydrochloride (Paxil)

10-, 20-, 30-, and 40-milligram (mg)

capsules 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 paroxetine

hydrochloride 10-, 20-, 30-, and 40-mg

capsules.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20855, 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 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,’’

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)). Under § 314.161(a)(1) (21

CFR 314.161(a)(1)) 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. FDA may not approve

an ANDA that does not refer to a listed

drug.

In a citizen petition dated December

28, 1999 (Docket No. 00P–0090/CP1),

submitted under 21 CFR 10.25(a), 10.30,

and 314.122, Pentech Pharmaceuticals,

Inc., requested that the agency

determine whether paroxetine

hydrochloride (Paxil) 10-, 20-, 30-, and

40-mg capsules were withdrawn or

withheld from sale for reasons of safety

or effectiveness. Paroxetine

hydrochloride (Paxil) 10-, 20-, 30-, and

40-mg capsules are the subject of

approved NDA 20–885 held by

SmithKline Beecham Pharmaceuticals

(SKB). SKB obtained approval to market

the 10-, 20-, 30-, and 40-mg strengths of

paroxetine hydrochloride capsules on

October 9, 1998. SKB has never

marketed the 10-, 20-, 30-, and 40-mg

strengths of paroxetine hydrochloride

capsules. 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 from sale.

FDA has reviewed its records and,

under §§ 314.161 and 314.162(c), has

determined that paroxetine

hydrochloride 10-, 20-, 30, and 40-mg

capsules were not withdrawn from sale

for reasons of safety or effectiveness.

Accordingly the agency will maintain

paroxetine hydrochloride 10-, 20-, 30-,

and 40-mg capsules in the

‘‘Discontinued Drug Product List’’

section of the Orange Book. The

‘‘Discontinued Drug Product List’’

identifies, among other items, drug

products that have been discontinued

from marketing for reasons other than

safety or effectiveness. ANDA’s that

refer to paroxetine hydrochloride 10-,

20-, 30-, and 40-mg capsules may be

approved by the agency.

Dated: June 14, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–15630 Filed 6–20–00; 8:45 am]

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