Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices 7583 

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was withdrawn from sale for reasons of 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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. 

JENLOGA (clonidine hydrochloride) 

Extended-Release Tablets, 0.1 mg and 

0.2 mg, are the subject of NDA 22–331, 

held by Shionogi Pharma, Inc., initially 

approved on September 29, 2009. 

JENLOGA is indicated for the treatment 

of hypertension. Shionogi Pharma has 

never marketed JENLOGA (clonidine 

hydrochloride) Extended-Release 

Tablets, 0.1 mg and 0.2 mg. In previous 

instances (see, e.g., 72 FR 9763, March 

5, 2007; 61 FR 25497, May 21, 1996), the 

Agency 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. 

Actavis, Inc. submitted a citizen 

petition dated April 20, 2011 (Docket 

No. FDA–2011–P–0291), under 21 CFR 

10.30, requesting that the Agency 

determine whether JENLOGA (clonidine 

hydrochloride) Extended-Release 

Tablets, 0.1 mg and 0.2 mg, were 

withdrawn from sale for reasons of 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 JENLOGA (clonidine 

hydrochloride) Extended-Release 

Tablets, 0.1 mg and 0.2 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that JENLOGA 

(clonidine hydrochloride) ExtendedRelease Tablets, 0.1 mg and 0.2 mg, 

were withdrawn from sale for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of JENLOGA 

(clonidine hydrochloride) ExtendedRelease Tablets, 0.1 mg and 0.2 mg, 

from sale. We have found no 

information that would indicate that 

these products were withdrawn from 

sale for reasons of safety or 

effectiveness. 

Accordingly, FDA will continue to list 

JENLOGA (clonidine hydrochloride) 

Extended-Release Tablets, 0.1 mg and 

0.2 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 JENLOGA 

(clonidine hydrochloride) ExtendedRelease Tablets, 0.1 mg and 0.2 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 7, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3222 Filed 2–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–P–0701] 

Determination That WILPO 

(phentermine hydrochloride) Tablets, 8 

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 WILPO (phentermine 

hydrochloride) Tablets, 8 Milligrams 

(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 phentermine 

hydrochloride tablets, 8 mg, if all other 

legal and regulatory requirements are 

met. 

FOR FURTHER INFORMATION CONTACT: Nam 

Kim, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6320, Silver Spring, 

MD 20993–0002, 301–796–3472. 

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 a new drug application 

(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 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. 

WILPO (phentermine hydrochloride) 

Tablets, 8 mg is the subject of NDA 

012737, held by Sandoz, Inc. WILPO is 

indicated in the management of 

exogenous obesity as a short term 

adjunct (a few weeks) in a regimen of 

weight reduction based on caloric 

restriction. 

WILPO (phentermine hydrochloride) 

Tablets, 8 mg, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

KVK–Tech, Inc. (KVK–Tech), 

submitted a citizen petition dated 

September 22, 2011 (Docket No. FDA– 

2011–P–0701), under 21 CFR 10.30, 

requesting that the Agency determine 

whether WILPO (phentermine 

hydrochloride) Tablets, 8 mg, was 

withdrawn from sale for reasons of 

safety or effectiveness. After considering 

the citizen petition and reviewing 


erowe on DSK2VPTVN1PROD with NOTICES
7584 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices 

Agency records and based on the 

information we have at this time, FDA 

has determined under § 314.161 that 

WILPO (phentermine hydrochloride) 

Tablets, 8 mg, was not withdrawn for 

reasons of safety or effectiveness. The 

petitioner KVK–Tech has identified no 

data or other information suggesting that 

WILPO (phentermine hydrochloride) 

Tablets, 8 mg, was withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

WILPO (phentermine hydrochloride) 

Tablets, 8 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 WILPO (phentermine 

hydrochloride) Tablets, 8 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 WILPO (phentermine hydrochloride) 

Tablets, 8 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 7, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3232 Filed 2–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0083] 

Draft Guidance for Industry on Heparin 

for Drug and Medical Device Use; 

Monitoring Crude Heparin for Quality; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Heparin for Drug and 

Medical Device Use: Monitoring Crude 

Heparin for Quality.’’ This draft 

guidance is intended to alert 

manufacturers of active pharmaceutical 

ingredients (APIs), pharmaceutical and 

medical device manufacturers of 

finished products, and others to the 

potential risk of crude heparin 

contamination. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

electronic or written comments on the 

draft guidance by April 13, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft 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. 

Submit electronic comments on the 

draft 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Frank W. Perrella, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4337, 

Silver Spring, MD 20993–0002, 301– 

796–3265; or Dennis M. Bensley, Jr., 

Center for Veterinary Medicine (HFV– 

140), Food and Drug Administration, 

7519 Standish Pl., Rockville, MD 20855, 

240–276–8268; or Jason Brookbank, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 3558, Silver Spring, MD 20993– 

0002, 301–796–5770. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Heparin for Drug and Medical Device 

Use: Monitoring Crude Heparin for 

Quality.’’ This draft guidance provides 

recommendations that will help API 

manufacturers, pharmaceutical and 

medical device manufacturers of 

finished products, and others, to better 

control their use of crude heparin that 

might contain oversulfated chondroitin 

sulfate (OSCS) or non-porcine material 

(especially ruminant material) 

contaminants. This draft guidance on 

crude heparin recommends strategies to 

test for contamination and should be 

used in addition to the United States 

Pharmacopeia (USP) monograph testing 

required for other forms of heparin to 

detect the presence of OSCS. 

Following reports of serious adverse 

events (including deaths) among 

patients injected with heparin sodium 

in 2008, FDA identified the contaminant 

OSCS in heparin API manufactured in 

China. FDA is also concerned about the 

potential for contamination of heparin 

with the bovine spongiform 

encephalopathy (BSE) agent derived 

from ruminant materials. The control of 

the quality of crude heparin is critical 

to ensure the safety of drugs and devices 

and to protect public health. FDA 

developed this draft guidance to alert 

manufacturers to the risks of crude 

heparin contaminants and to 

recommend strategies to ensure that the 

heparin supply chain is not 

contaminated with OSCS or any nonporcine origin material, especially 

ruminant material (unless specifically 

approved or cleared as part of drug or 

medical device application). 

The draft guidance recommends that 

manufacturers test and confirm the 

species origin of crude heparin in each 

shipment before use in the manufacture 

or preparation of a drug or medical 

device containing heparin. The test 

method should be qualified for use in 

testing crude heparin and for the 

identification of species origin. The 

method should be based on good 

scientific principles (e.g., sufficient 

accuracy and specificity) and possess a 

level of sensitivity commensurate with 

the current state of scientific knowledge 

and risk. Likewise, the draft guidance 

recommends that manufacturers test for 

OSCS in crude heparin in each 

shipment before use, using a qualified 

test method that is suitable for detecting 

low levels of OSCS concentrations and 

is based on good scientific principles. 

Manufacturers should reject for use and 

control or destroy crude heparin found 

to contain any amount of OSCS and 

notify FDA of any such finding. The 

draft guidance also recommends that 

manufacturers identify and audit crude 

heparin suppliers and heparin API 

suppliers to ensure conformance to 

current good manufacturing practice 

(CGMP), employ the controls described 

in the guidance for industry ‘‘Q7 Good 

Manufacturing Practice Guidance for 

Active Pharmaceutical Ingredients,’’ and 

comply with the quality system 

regulations (as applicable). 

This draft guidance is being issued 

consistent with FDA’s good guidance 


erowe on DSK2VPTVN1PROD with NOTICES