43538 Federal Register / Vol. 62, No. 157 / Thursday, August 14, 1997 / Notices

VII. Legal Status

Levothyroxine sodium is used as

replacement therapy when endogenous

thyroid hormone production is

deficient. The maintenance dosage must

be determined on a patient-by-patient

basis. Levothyroxine sodium products

are marketed in multiple dosage

strengths, that may vary by only 12

micrograms, thus permitting careful

titration of dose. Because of

levothyroxine sodium’s narrow

therapeutic index, it is particularly

important that the amount of available

active drug be consistent for a given

tablet strength.

Variations in the amount of available

active drug can affect both safety and

effectiveness. Patients who receive

superpotent tablets may experience

angina, tachycardia, or arrhythmias.

There is also evidence that

overtreatment can cause osteoporosis.

Subpotent tablets will not be effective in

controlling hypothyroid symptoms or

sequelae.

The drug substance levothyroxine

sodium is unstable in the presence of

light, temperature, air, and humidity.

Unless the manufacturing process can

be carefully and consistently controlled,

orally administered levothyroxine

sodium products may not be fully

potent through the labeled expiration

date, or be of consistent potency from

lot to lot.

There is evidence from recalls,

adverse drug experience reports, and

inspection reports that even when a

physician consistently prescribes the

same brand of orally administered

levothyroxine sodium, patients may

receive products of variable potency at

a given dose. Such variations in product

potency present actual safety and

effectiveness concerns.

In conclusion, the active ingredient

levothyroxine sodium is effective in

treating hypothyroidism and is safe

when carefully and consistently

manufactured and stored, and

prescribed in the correct amount to

replace the deficiency of thyroid

hormone in a particular patient.

However, no currently marketed orally

administered levothyroxine sodium

product has been shown to demonstrate

consistent potency and stability and,

thus, no currently marketed orally

administered levothyroxine sodium

product is generally recognized as safe

and effective. Accordingly, any orally

administered drug product containing

levothyroxine sodium is a new drug

under section 201(p) of the act (21

U.S.C. 321(p)) and is subject to the

requirements of section 505 of the act.

Manufacturers who wish to continue

to market orally administered

levothyroxine sodium products must

submit applications as required by

section 505 of the act and part 314 (21

CFR part 314). FDA is prepared to

accept NDA’s for these products,

including section 505(b)(2) applications.

An applicant making a submission

under section 505(b)(2) of the act may

rely upon investigations described in

section 505(b)(1)(A) that were not

conducted by or for the applicant and

for which the applicant has not obtained

a right of reference or use from the

person by or for whom the

investigations were conducted. For

example, such an application may

include literature supporting the safety

and/or the effectiveness of

levothyroxine sodium. A bioavailability

study must be completed and submitted

as part of an NDA, including a 505(b)(2)

application, in order to evaluate the

safety and efficacy of these products.

If the manufacturer of an orally

administered drug product containing

levothyroxine sodium contends that the

drug product is not subject to the new

drug requirements of the act, this claim

should be submitted in the form of a

citizen petition under § 10.30 and

should be filed to Docket No. 97N–0314

no later than October 14, 1997. Sixty

days is the time allowed for such

submissions in similar proceedings.

(See § 314.200(c) and (e).) Under

§ 10.30(e)(2), the agency will provide a

response to each petitioner within 180

days of receipt of the petition. A citizen

petition that contends that a particular

drug product is not subject to the new

drug requirements of the act should

contain the quality and quantity of data

and information set forth in

§ 314.200(e). Note especially that a

contention that a drug product is

generally recognized as safe and

effective within the meaning of section

201(p) of the act is to be supported by

the same quantity and quality of

scientific evidence that is required to

obtain approval of an application for the

product. (See § 314.200(e)(1).)

Levothyroxine sodium products are

medically necessary because they are

used to treat hypothyroidism and no

alternative drug is relied upon by the

medical community as an adequate

substitute. Accordingly, FDA will

permit orally administered

levothyroxine sodium products to be

marketed without approved NDA’s until

August 14, 2000, in order to give

manufacturers time to conduct the

required studies and to prepare and

submit applications, and to allow time

for review of and action on these

applications. This provision for

continuation of marketing, which

applies only to levothyroxine sodium

products marketed on or before the

publication of this notice, is consistent

with the order in Hoffmann-La Roche,

Inc. v. Weinberger, 425 F. Supp. 890

(D.D.C. 1975), reprinted in the Federal

Register of September 22, 1975 (40 FR

43531) and March 2, 1976 (41 FR 9001).

After August 14, 2000 any orally

administered drug product containing

levothyroxine sodium, marketed on or

before the date of this notice, that is

introduced or delivered for introduction

into interstate commerce without an

approved application will be subject to

regulatory action, unless there has been

a finding by FDA, under a citizen

petition submitted for that product as

described above, that the product is not

subject to the new drug requirements of

the act.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 502, 505 (21 U.S.C. 352, 355)) and

under authority delegated to the Deputy

Commissioner for Policy (21 CFR 5.20).

Dated: August 7, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–21575 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

National Consumer Forum; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

SUMMARY: The Food and Drug

Administration (FDA), Office of

Consumer Affairs (OCA), is announcing

the first in a series of National

Consumer Forums. These forums are an

opportunity to engage in open dialog

with consumers on health issues and

agency actions.

DATES: The meeting will be held on

Tuesday, September 23, 1997, from 1

p.m. to 3 p.m. Due to space limitations,

preregistration is recommended

ADDRESSES: The meeting will be held in

the Truman Room of the White House

Conference Center, 726 Jackson Pl. NW.,

Washington, DC 20006. Use Metro Stop

Farragut North, K Street Exit on the Red

Line, and Farragut West on Blue/Orange

Line.

FOR FURTHER INFORMATION CONTACT:

Carol M. Lewis, Office of Consumer
Federal Register / Vol. 62, No. 157 / Thursday, August 14, 1997 / Notices 43539

Affairs (HFE–1), Food and Drug

Administration, Parklawn Bldg., 5600

Fishers Lane, rm. 16–85, Rockville, MD

20857, 301–827–4404, FAX 301–827–

3052, or e-mail

‘‘clewis@bangate.fda.gov’’.

SUPPLEMENTARY INFORMATION: The

purpose of this meeting is to provide an

opportunity for consumers to discuss

their concerns and thereby participate

in agency decision and policymaking on

key health care and consumer

protection issues. To register for the

meeting and obtain directions, please

call, fax, or e-mail the contact person

(address above). Include the name, title,

telephone and fax numbers of the

person attending, and the name of the

organization being represented.

If special accommodations are

required due to a disability, please

contact Carol M. Lewis at least 7 days

in advance of the meeting.

Dated: August 8, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–21573 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of public advisory committees

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committees: Joint meeting of

the Nonprescription Drugs Advisory

Committee and Pulmonary-Allergy

Drugs Advisory Committee.

General Function of the Committees:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on September 19, 1997, 8:30 a.m.

to 5 p.m.

Location: Holiday Inn, Ballroom, Two

Montgomery Village Ave., Gaithersburg,

MD.

Contact Person: Andrea G. Neal or

Leander B. Madoo, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), codes 12541 and

12545. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committees will jointly

consider new drug application (NDA)

20–840, Beconase Allergy Nasal Spray

(belcomethasone dipropionate 0.042%,

monohydrate, Glaxo Wellcome, Inc.) for

over-the-counter treatment and

prevention of the symptoms of seasonal

allergic rhinitis in patients 12 years of

age and older.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by September 5, 1997. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. to 9:30 a.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before September 5, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: August 7, 1997.

William B. Schultz,

Acting Lead Deputy Commissioner for the

Food and Drug Administration.

[FR Doc. 97–21571 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Nonprescription

Drugs Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on September 18, 1997, from 8:30

a.m. to approximately 5 p.m.

Location: Holiday Inn, The Ballroom,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact Person: Andrea G. Neal,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12541. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The Committee will discuss

issues relating to the labeling and

dosing of over-the-counter (OTC)

pediatric analgesic/antipyretic drug

products. The Committee will discuss

topics such as: (1) What is an

appropriate lower age limit for the

dosing of OTC analgesic/antipyretic

drug products; and (2) the safety

implications of the OTC availability of

children’s analgesic/antipyretic

suspension products and double

concentrated infant drops with

overlapping age directions.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by September 12, 1997. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before September 12, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C., app. 2).

Dated: August 7, 1997.

William B. Schultz,

Acting Lead Deputy Commissioner for the

Food and Drug Administration.

[FR Doc. 97–21574 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.