39450 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 

Generic Clearance for the Collection of 

Quantitative Data on Tobacco Products 

and Communications; OMB Control 

Number 0910–0810—Extension 

In order to conduct educational and 

public information programs relating to 

tobacco use as authorized by section 

1003(d)(2)(D) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(D)), FDA’s Center for Tobacco 

Products will create and use a variety of 

media to inform and educate the public, 

tobacco retailers, and health 

professionals about the risks of tobacco 

use, how to quit using tobacco products, 

and FDA’s role in regulating tobacco. 

To ensure that these health 

communication messages have the 

highest potential to be received, 

understood, and accepted by those for 

whom they are intended, the Center for 

Tobacco Products will conduct research 

and studies relating to the control and 

prevention of disease. In conducting 

such research, FDA will employ 

formative pretests. Formative pretests 

are conducted on a small scale, and 

their focus is on developing and 

assessing the likely effectiveness of 

communications with specific target 

audiences. This type of research 

involves: (1) Assessing audience 

knowledge, attitudes, behaviors, and 

other characteristics for the purpose of 

determining the need for and 

developing health messages, 

communication strategies, and public 

information programs and (2) pretesting 

these health messages, strategies, and 

program components while they are in 

developmental form to assess audience 

comprehension, reactions, and 

perceptions. 

Formative pretesting is a staple of best 

practices in communications research. 

Obtaining voluntary feedback from 

intended audiences during the 

development of messages and materials 

is crucial for the success of every 

communication program. The purpose 

of obtaining information from formative 

pretesting is that it allows FDA to 

improve materials and strategies while 

revisions are still affordable and 

possible. Formative pretesting can also 

avoid potentially expensive and 

dangerous unintended outcomes caused 

by audiences’ interpreting messages in a 

way that was not intended by the 

drafters. By maximizing the 

effectiveness of messages and strategies 

for reaching targeted audiences, the 

frequency with which tobacco 

communication messages need to be 

modified should be greatly reduced. 

The voluntary information collected 

will serve the primary purpose of 

providing FDA information about the 

perceived effectiveness of messages, 

advertisements, and materials in 

reaching and successfully 

communicating with their intended 

audiences. Quantitative testing 

messages and other materials with a 

sample of the target audience will allow 

FDA to refine messages, advertisements, 

and materials, including questionnaires 

or images, directed at consumers while 

the materials are still in the 

developmental stage. 

In the Federal Register of February 

13, 2018 (83 FR 6190), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. One PRA-related comment 

was received. 

Comment: The comment recommends 

that FDA should research and develop 

communications about educating adults 

about the continuum of risk, and 

educating adults to not provide tobacco 

products to youth. 

Response: FDA appreciates the 

comment. The content and focus on 

studies submitted through this generic 

clearance will depend on Agency 

priorities and needs, and is not yet 

determined at this time. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Screener ............................................................................... 130,500 1 130,500 0.083 (5 

minutes) 

10,831 

Self-Administered Surveys ................................................... 27,000 1 27,000 0.33 (20 

minutes) 

8,910 

Total .............................................................................. ........................ ........................ ........................ ........................ 19,741 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The number of respondents to be 

included in each new survey will vary, 

depending on the nature of the material 

or message being tested and the target 

audience. The burden for this 

information collection extension is 

proposed to increase by 12,613 hours 

since the last OMB approval. The 

burden increase is due to an increase in 

the number of respondents and the 

categories of respondents. 

Dated: August 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17044 Filed 8–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2495] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Voluntary Labeling 

Indicating Whether Foods Have or 

Have Not Been Derived From 

Genetically Engineered Plants 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection associated with the guidance 

to assist manufacturers who wish to 

voluntarily label their foods (human and 

animal) as being made with or without 

bioengineering, or the use of 

bioengineered ingredients, to ensure 

that labeling is truthful and not 

misleading. 


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Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 39451 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 9, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before October 9, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 9, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–2495 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Voluntary Labeling Indicating Whether 

Foods Have or Have Not Been Derived 

from Genetically Engineered Plants.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 

9 a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Voluntary Labeling Indicating Whether 

Foods Have or Have Not Been Derived 

From Genetically Engineered Plants 

OMB Control Number 0910–0807— 

Extension 

This information collection supports 

Agency guidance. Section 403 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 343) generally 

governs the labeling of foods. Under 

section 403(a)(1) of the FD&C Act, a 

food is misbranded if its labeling is false 

or misleading in any particular. Section 

201(n) of the FD&C Act (21 U.S.C. 

321(n)) provides that labeling is 

misleading if, among other things, it 

fails to reveal facts that are material in 

light of representations made or 

suggested in the labeling, or material 

with respect to consequences that may 

result from the use of the food to which 

the labeling relates under the conditions 

of use prescribed in the labeling, or 


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39452 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 

under such conditions of use as are 

customary or usual. 

In the Federal Register of May 29, 

1992 (57 FR 22984), we published a 

‘‘Statement of Policy: Foods Derived 

from New Plant Varieties’’ (the 1992 

Policy). The 1992 Policy applies to 

foods for humans and animals that are 

developed from new plant varieties, 

including varieties that are developed 

using recombinant deoxyribonucleic 

acid (rDNA) technology, which is often 

referred to as ‘‘rDNA technology,’’ 

‘‘genetic engineering,’’ ‘‘biotechnology,’’ 

or ‘‘bioengineering,’’ and more recently 

as ‘‘modern biotechnology.’’ The 1992 

Policy provides guidance to industry on 

scientific and regulatory issues related 

to bioengineered foods and solicited 

written comments from interested 

persons. It includes guidance on 

questions to be answered by developers 

of foods from new plant varieties to 

ensure that the new products are safe 

and comply with applicable legal 

requirements. 

The 1992 Policy stated that the 

method of development of a new plant 

variety, including plants developed 

using bioengineering, is not information 

that is material under section 201(n) of 

the FD&C Act and, therefore, would not 

be required in the labeling of food. This 

conclusion is consistent with our 

historic interpretation of section 201(n) 

of the FD&C Act, in that the method of 

plant breeding is not required to be 

disclosed in labeling. In the 1992 Policy, 

we addressed, among other things, the 

labeling of foods derived from new 

plant varieties, including plants 

developed by bioengineering. In the 

1992 Policy, we explained that we were 

not establishing special labeling 

requirements for foods from 

bioengineered plants as a class of foods 

because we did not find any basis for 

concluding that foods from 

bioengineered plants, as a class, differ 

from other foods in any meaningful or 

uniform way, or that foods developed by 

the new techniques present any 

different or greater safety concern than 

foods developed by traditional plant 

breeding. 

The guidance entitled ‘‘Voluntary 

Labeling Indicating Whether Foods 

Have or Have Not Been Derived from 

Genetically Engineered Plants’’ is 

intended to assist manufacturers that 

wish to voluntarily label their foods 

(human or animal) as being made with 

or without genetic engineering or the 

use of genetically engineered 

ingredients, to ensure that such labeling 

is truthful and not misleading. The 

guidance is available at https://

www.fda.gov/FoodGuidances. The 

information that the manufacturers will 

collect is documentation of handling 

practices so that they can truthfully 

label their products to indicate, if they 

so choose, whether the food has or has 

not been developed using genetic 

engineering. 

In general, we anticipate that 

manufacturers that claim that a product 

is not developed using bioengineered 

material would substantiate the claim. 

We suggest that manufacturers 

document practices and procedures to 

substantiate a claim that a food was not 

developed using genetic engineering. 

Examples of documentation that we 

anticipate will demonstrate practices 

and procedures are recordkeeping, and 

certifications or affidavits from farmers, 

processors, and others in the food 

production and distribution chain. We 

are neither suggesting that firms 

maintain a certain set list of documents 

nor are we suggesting that anything less 

or different would likely be considered 

unacceptable. Rather, we are leaving it 

to each firm’s judgment to maintain 

appropriate documentation to 

demonstrate that the food was produced 

using traditional methods. 

Description of Respondents: The 

respondents to the proposed collection 

of information are manufacturers of 

foods that were or were not derived 

from genetically engineered plants who 

wish to voluntarily label their food 

products. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Recordkeeping per the Guidance ........................................ 85 4 340 1 340 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

The number of recordkeepers and 

respondents reflects the number of food 

products that are labeled using the 

terms ‘‘biotechnology’’ and ‘‘GMO’’ 

(genetically modified organism). We 

estimate a recordkeeping burden to 

retain paperwork to substantiate that the 

food or ingredient is produced without 

genetic engineering only for products 

that are not also already labeled using 

the term ‘‘organic.’’ We did not include 

products that are labeled ‘‘organic’’ in 

the estimated annual recordkeeping 

burden because, according to a final rule 

in the Federal Register of December 21, 

2000 (65 FR 80548) issued by the 

Agriculture Marketing Service of the 

U.S. Department of Agriculture, a food 

labeled as ‘‘organic’’ would not be 

permitted to contain genetically 

engineered materials. Thus, there is no 

additional paperwork burden to 

substantiate a claim that a product is not 

developed using genetic engineering for 

these certified organic products. 

We based our estimates of the 

recordkeeping burden (table 1 of this 

document) on data from Labelbase by 

FoodEssentials. Labelbase is a custom 

online system for accessing consumerpackaged goods product data; the 

database contains more than 250,000 

product labels that can be searched by 

keyword, ingredient, nutrient, allergen, 

label claim, or food additive, for 

example. Using this database, we have 

identified 540 food manufacturers who 

produce 2,160 products with the term 

‘‘bioengineered’’ or ‘‘GMO’’ on their 

labels; this estimate includes 

manufacturers of human food and pet 

food. In addition, the National Center 

for Appropriate Technology’s National 

Sustainable Agriculture Information 

Center maintains on its website a list of 

Organic Livestock Feed Suppliers. 

Using this list, we have identified 54 

livestock feed suppliers that would be 

likely to include a statement about 

bioengineering on the label of their 

products and thus would have 

documentation to substantiate their 

claim. 

Of the 2,160 human food and pet food 

products that we have identified as 

using the term ‘‘bioengineered’’ or 

‘‘GMO’’ on their labels (presumably 

used in a context to designate foods that 

are not bioengineered), 1,140 of these 

products (285 manufacturers) also use 

the term ‘‘organic’’ on the label; 1,020 

products do not use the term ‘‘organic’’ 


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Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 39453 

on the label (2,160 ¥ 1,140 = 1,020 

products not organics; 540 ¥ 285 = 255 

manufacturers of not organic products). 

In addition, the 54 livestock feed 

suppliers are also organic producers, 

thus the 216 products attributed to these 

manufacturers already are considered to 

be labeled ‘‘organic.’’ Thus, there are 

1,020 products made by 255 human 

food and pet food manufacturers that 

would need to substantiate that their 

product or ingredient was not 

genetically engineered. 

We estimate that the burden of 

maintaining the documentation is a onetime burden; the document to 

substantiate that the product or 

ingredient was produced without 

genetic engineering only needs to be 

generated once and then kept on file. To 

annualize this one-time burden, we 

divide by 3 because paperwork burden 

collections are approved on a 3-year 

cycle (255/3 = 85). Thus, we estimate in 

table 1 that, on average, 85 

manufacturers annually will collect and 

keep information that substantiates their 

label claim for four products (1,020 

products/3 = 340 products/85 

manufacturers = 4 products per 

manufacturer). 

We estimate this one-time 

recordkeeping burden to be 1 hour per 

product that makes use of a labeling 

claim, which results in a burden of 1 

hour for a total annualized 

recordkeeping burden of 340 hours (85 

manufacturers × 4 records per 

manufacturer × 1 hour per record). 

We do not estimate any reporting 

burden or third-party disclosure burden 

associated with this information 

collection. Manufacturers who want to 

make use of this voluntary labeling 

claim option are considered to be those 

that already have such wording on their 

products’ labels. We do not expect that 

this guidance will cause labels already 

in the marketplace to need to be 

reworded. 

Dated: August 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17024 Filed 8–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–P–0998] 

Determination That PROLIXIN 

(Fluphenazine Hydrochloride) Tablets, 

1 Milligram, 2.5 Milligrams, 5 

Milligrams, and 10 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 or Agency) has 

determined that PROLIXIN 

(fluphenazine hydrochloride) tablets, 1 

milligram (mg), 2.5 mg, 5 mg, and 10 

mg, was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for fluphenazine 

hydrochloride tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted 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 under an 

ANDA procedure. ANDA applicants 

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. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of an NDA. 

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 known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed 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). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

PROLIXIN (fluphenazine 

hydrochloride) tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg, is the subject of NDA 

011751, held by Apothecon 

Pharmaceuticals, a Bristol-Myers Squibb 

Company, and initially approved on 

March 15, 1967. PROLIXIN is indicated 

in the management of manifestations of 

psychotic disorders. 

In a letter dated October 5, 2006, 

Bristol-Myers Squibb Company 

requested withdrawal of NDA 011751 

for PROLIXIN (fluphenazine 

hydrochloride) tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg. In the Federal Register 

of February 11, 2009 (74 FR 6896), FDA 

announced that it was withdrawing 

approval of NDA 011751, effective 

March 13, 2009. 

Hyman, Phelps & McNamara, P.C. 

submitted a citizen petition dated 

March 5, 2018 (Docket No. FDA–2018– 

P–0998), under 21 CFR 10.30, 

requesting that the Agency determine 

whether PROLIXIN (fluphenazine 

hydrochloride) tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg, was withdrawn from 

sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that PROLIXIN (fluphenazine 

hydrochloride) tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg, was not withdrawn for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that PROLIXIN 

(fluphenazine hydrochloride) tablets, 1 

mg, 2.5 mg, 5 mg, and 10 mg, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of PROLIXIN 

(fluphenazine hydrochloride) tablets, 1 

mg, 2.5 mg, 5 mg, and 10 mg, from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 


sradovich on DSK3GMQ082PROD with NOTICES