12310 Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 

1A ‘‘new drug’’ is defined by the FD&C Act as 

a drug that ‘‘is not generally recognized, among 

experts qualified by scientific training and 

experience to evaluate the safety and effectiveness 

of drugs, as safe and effective for use under the 

conditions prescribed, recommended, or suggested 

in the labeling thereof, except that such a drug not 

so recognized shall not be deemed to be a ‘new 

drug’ if at any time prior to the enactment of this 

Act it was subject to the Food and Drugs Act of June 

30, 1906, as amended, and if at such time its 

labeling contained the same representations 

concerning the conditions of its use * * *.’’ (21 

U.S.C. 321(p)). 

2Section 310.6(b)(1) ((21 CFR 310.6(b)(1)) 

provides: ‘‘An identical, related, or similar drug 

includes other brands, potencies, dosage forms, 

salts, and esters of the same drug moiety as well as 

of any drug moiety related in chemical structure or 

known pharmacological properties.’’ 

PHENURONE (phenacemide) Tablet, 

500 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 product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list PHENURONE 

(phenacemide) Tablet, 500 mg, 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. ANDAs that refer 

to PHENURONE (phenacemide) Tablet, 

500 mg, may be approved by the Agency 

as long as they meet all other legal and 

regulatory requirements for the approval 

of ANDAs. If FDA determines that 

labeling for this drug product should be 

revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: February 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4783 Filed 2–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1978–N–0441] (formerly 

78N–0324); DESI 10392] 

Drugs for Human Use; Drug Efficacy 

Study Implementation; Prescription 

Drugs That Contained Hydroxyzine 

Hydrochloride or Hydroxyzine 

Pamoate; Final Resolution of Docket 

ACTION: Notice; withdrawal of a hearing 

request. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that all outstanding hearing requests 

pertaining to Docket FDA–1978–N–0441 

(formerly 78N–0324) have been 

withdrawn. Therefore, shipment in 

interstate commerce of any of the 

products identified in that docket, or 

any identical, related, or similar (IRS) 

product that is not the subject of an 

approved new drug application (NDA) 

or abbreviated new drug application 

(ANDA) (other than an over-the-counter 

(OTC) product that complies with an 

applicable OTC monograph), is 

unlawful as of the effective date of this 

notice. 

DATES: Effective Date: This notice is 

effective February 29, 2012. 

ADDRESSES: All communications in 

response to this notice should be 

identified with the docket number 

found in brackets in the heading of this 

document, and directed to Pamela Lee, 

Office of Unapproved Drugs and 

Labeling Compliance, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 5173, 

Silver Spring, MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Pamela Lee, Office of Unapproved Drugs 

and Labeling Compliance, Office of 

Compliance, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5173, Silver Spring, 

MD 20993–0002, 301–796–3297, email: 

pamela.lee@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

When initially enacted in 1938, the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) required that ‘‘new 

drugs’’ be approved for safety by FDA 

before they could legally be sold in 

interstate commerce.1 To this end, the 

FD&C Act made it the sponsor’s 

responsibility, before marketing a new 

drug, to submit an NDA to FDA to prove 

that its drug was safe. Between 1938 and 

1962, if a drug obtained approval, FDA 

considered drugs that were IRS 2 to the 

approved drug to be ‘‘covered’’ by that 

approval, and allowed those IRS drugs 

to be marketed without independent 

approval. 

In 1962, Congress amended the FD&C 

Act to require that new drugs be proven 

effective for their labeled indications, as 

well as safe, to obtain FDA approval. 

This amendment also caused FDA to 

conduct a retrospective evaluation of 

the effectiveness of the drug products 

that FDA had approved as safe between 

1938 and 1962. FDA contracted with the 

National Academy of Sciences/National 

Research Council (NAS/NRC) to make 

an initial evaluation of the effectiveness 

of over 3,400 products that had been 

approved only for safety between 1938 

and 1962. The NAS/NRC reports for 

these drug products were submitted to 

FDA in the late 1960s and early 1970s. 

The Agency reviewed and re-evaluated 

the reports and published its findings in 

Federal Register notices. FDA’s 

administrative implementation of the 

NAS/NRC reports was called the Drug 

Efficacy Study Implementation (DESI). 

DESI covered the approximately 3,400 

products specifically reviewed by the 

NAS/NRC, as well as the even larger 

number of IRS products that entered the 

market without FDA approval. 

All drugs covered by the DESI review 

are ‘‘new drugs’’ under the FD&C Act. 

If FDA’s final DESI determination 

classifies a drug product as lacking 

substantial evidence of effectiveness for 

one or more indications, that drug 

product and those IRS to it may no 

longer be marketed for the indications 

and are subject to enforcement action as 

unapproved new drugs. If FDA’s final 

DESI determination classifies the drug 

product as effective for one or more of 

its labeled indications, the drug can be 

marketed for those indications, 

provided it is the subject of an 

application approved for safety and 

effectiveness. Sponsors of drug products 

that have been found to be effective for 

one or more indications through the 

DESI process may rely on FDA’s 

effectiveness determinations, but 

typically must update their labeling to 

conform to the indication(s) found to be 

effective by FDA and include any 

additional safety information required 

by FDA. Those drug products with 

NDAs approved before 1962 for safety 

therefore require approved supplements 

to their original applications if one or 

more indications are found to be 

effective under DESI; IRS drug products 

require an approved NDA or ANDA, as 

appropriate. Furthermore, labeling for 

drug products classified as effective may 

contain only those indications for which 

the review found the product effective, 

unless the firm marketing the product 

has received an approval for the 

additional indication(s). 

II. Docket No. FDA–1978–N–0441 

(formerly 78N–0324); DESI 10392 

Under Docket No. FDA–1978–N–0441 

(formerly 78N–0324), FDA evaluated the 

evidence of effectiveness for various 

indications for Atarax Tablets (NDA 10– 

392), Atarax Syrup (NDA 10–485), 

Vistaril Injection (NDA 11–111), Vistaril 

Capsules (NDA 11–459), and Vistaril 

Oral Suspension (NDA 11–795), 

products owned by Pfizer, Inc. (Pfizer), 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 12311 

and B. Roerig & Co., then a division of 

Pfizer, that contained hydroxyzine 

hydrochloride and hydroxyzine 

pamoate (44 FR 6780, February 2, 1979) 

(the February 1979 Federal Register 

notice). Although some indications for 

these products were found to be 

supported by adequate and wellcontrolled clinical studies, other 

indications were determined to be 

lacking substantial evidence of 

effectiveness (Id.). The February 1979 

Federal Register notice offered an 

opportunity for hearing with respect to 

the indications found to be lacking 

substantial evidence of effectiveness, as 

well as with respect to any issues 

relating to the legal status of the drug 

products subject to it. 

In response to the February 1979 

Federal Register notice, Pfizer requested 

a hearing. No other companies 

requested a hearing. On November 22, 

2010, FDA sent a letter to Pfizer to 

determine whether Pfizer remained 

interested in pursuing its hearing 

request. On December 22, 2010, Pfizer 

responded by withdrawing its hearing 

request. There are no longer outstanding 

hearing requests pertaining to Docket 

No. FDA–1978–N–0441 (formerly 78N– 

0324). Therefore, shipment in interstate 

commerce of any product identified in 

this docket, or any IRS product, that is 

not the subject of an approved NDA or 

ANDA is unlawful as of the effective 

date of this notice. This notice is not 

applicable to OTC products that comply 

with an OTC monograph (21 CFR 

310.6(f)). Any person who wishes to 

determine whether a specific product is 

covered by this notice should write to 

the Center for Drug Evaluation and 

Research (see ADDRESSES). 

III. Discontinued Products 

Some firms may have previously 

discontinued the manufacturing or 

distribution of products covered by this 

notice without removing them from the 

listing of their products under section 

510(j) of the FD&C Act (21 U.S.C. 

360(j)). Other firms may discontinue 

manufacturing or marketing listed 

products in response to this notice. 

Firms that wish to notify the Agency of 

product discontinuation should send a 

letter, signed by the firm’s chief 

executive officer, fully identifying the 

discontinued product(s), including 

National Drug Code (NDC) number(s), 

and stating that the product(s) have 

been discontinued. The letter should be 

sent to Pamela Lee (see ADDRESSES). 

Firms should also update the listing 

of their products under section 510(j) of 

the FD&C Act to reflect discontinuation 

of unapproved products. FDA plans to 

rely on its existing records, including 

drug listing records or other available 

information, when it targets violations 

for enforcement action. Firms should be 

aware that after the effective date of this 

notice, FDA intends to take enforcement 

action without further notice against 

any firm that manufactures or ships in 

interstate commerce any unapproved 

product covered by this notice. 

IV. Reformulated Products 

FDA cautions firms against 

reformulating products into OTC 

products or different unapproved new 

drugs that are marketed under the same 

name or substantially the same name 

(including a new name that contains the 

old name). Reformulated products 

marketed under a name previously 

identified with a different active 

ingredient or combination of active 

ingredients have the potential to 

confuse health care practitioners and 

harm patients. 

This notice is issued under the FD&C 

Act (sections 502 and 505 (21 U.S.C. 352 

and 355)), and under authority 

delegated to the Deputy Commissioner 

for Policy under section 1410.10 of the 

FDA Staff Manual Guide. 

Dated: February 17, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–4781 Filed 2–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0024] 

Guidance for Industry on Size of Beads 

in Drug Products Labeled for Sprinkle; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Size of Beads in Drug Products 

Labeled for Sprinkle.’’ This guidance 

provides applicants preparing or 

submitting new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), and biologics 

licensing applications (BLAs) the Center 

for Drug Evaluation and Research’s 

(CDER’s) current thinking on 

appropriate size ranges for beads in drug 

products that are labeled to be 

administered via sprinkling (e.g., 

capsules or packets containing beads). 

In the Federal Register of January 19, 

2011 (76 FR 3144), FDA announced the 

availability of the draft version of this 

guidance. The public comment period 

closed on April 19, 2011. A number of 

comments were received from the 

public, all of which the Agency 

considered carefully as it finalized the 

guidance and made appropriate 

changes. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Laurie Muldowney, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 51, rm. 

4154, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–1571. 

SUPPLEMENTARY INFORMATION:

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Size of 

Beads in Drug Products Labeled for 

Sprinkle.’’ This guidance provides 

applicants preparing or submitting 

NDAs, ANDAs, and BLAs CDER’s 

current thinking on appropriate size 

ranges for beads in drug products that 

are labeled to be administered via 

sprinkling (e.g., capsules or packets 

containing beads). 

Certain drug products that contain 

beads within a capsule indicate in the 

labeling that the capsule can be broken 

and the internal beads can be sprinkled 

on soft foods and swallowed without 

chewing as an alternative 

administration technique. This is 

particularly common with drug 

products designed to have extended- or 

delayed-release characteristics (i.e., the 

beads are manufactured to release the 

drug product at different rates). To make 

certain that the intended product 

performance is achieved—whether from 

a capsule that has been broken or from 


tkelley on DSK3SPTVN1PROD with NOTICES