Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices 1619 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007P–0295] 

Determination That INDERAL 

(Propranolol Hydrochloride) Tablets, 

10 Milligrams, 20 Milligrams, and 90 

Milligrams Were Not Withdrawn From 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 INDERAL (propranolol 

hydrochloride (HCl)) Tablets, 10 

milligrams (mg), 20 mg, and 90 mg, 

were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to the drug products, 

and it will allow FDA to approve 

ANDAs for propranolol HCl tablets, 10 

mg, 20 mg, and 90 mg as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Mary Catchings, Center for Drug 

Evaluation and Research (HFD–7), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

2041. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) (the 1984 amendments), 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. 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 generally known 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). 

Under § 314.161(a) (21 CFR 

314.161(a)), the agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) Before an ANDA that 

refers to that listed drug may be 

approved or (2) whenever a listed drug 

is voluntarily withdrawn from sale, and 

ANDAs that referred to the listed drug 

have been approved. Section 314.161(d) 

provides that if FDA determines that the 

listed drug was removed from sale for 

safety or effectiveness reasons, the 

agency will initiate proceedings that 

could result in the withdrawal of 

approval of the ANDAs that refer to the 

listed drug. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

INDERAL (propranolol HCl) Tablets, 

10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 

90 mg, are the subject of approved NDA 

16–418 held by Wyeth Pharmaceuticals, 

Inc. (Wyeth). INDERAL is indicated in 

the treatment of hypertension, angina 

pectoris, atrial fibrillation, myocardial 

infarction, migraine headaches, 

essential tremors, hypertrophic 

subaortic stenosis, and 

pheochromocytoma. In tablet form, 

INDERAL is currently available in 40-, 

60-, and 80-mg strengths. Wyeth 

discontinued marketing the tablet form 

in the 10-, 20-, and 90-mg strengths, and 

those products were moved from the 

prescription drug product list to the 

‘‘Discontinued Drug Product List’’

section of the Orange Book. 

In a citizen petition dated July 20, 

2007 (Docket No. 2007P–0295/CP1), 

submitted under 21 CFR 10.25(a) and 

10.30, Regulus Pharmaceutical 

Consulting, Inc., requested that the 

agency determine, as described in 

§ 314.161, whether INDERAL 

(propranolol HCl) Tablets, 10 mg and 20 

mg, were withdrawn from sale for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that INDERAL 

Tablets, 10 mg and 20 mg, were 

withdrawn from sale as a result of safety 

or effectiveness concerns. Although the 

citizen petition did not address the 90- 

mg strength, FDA must make a 

determination regarding whether that 

strength was withdrawn for safety or 

efficacy reasons because generic 

versions of that strength are currently 

being marketed. 

We have reviewed our records and 

determined that INDERAL Tablets, 10 

mg, 20 mg, and 90 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events and have 

found no information that would 

indicate that INDERAL Tablets, 10 mg, 

20 mg, and 90 mg, were withdrawn from 

sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing its records, FDA has 

determined that, for the reasons 

outlined in this notice, INDERAL 

(propranolol HCl) Tablets, 10 mg, 20 

mg, and 90 mg, were not withdrawn 

from sale for reasons of safety or 

effectiveness. Accordingly, the agency 

will continue to list INDERAL 

(propranolol HCl) Tablets, 10 mg, 20 

mg, and 90 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 INDERAL 

(propranolol HCl) Tablets, 10 mg, 20 

mg, and 90-mg, may be approved by the 

agency as long as they comply with 

relevant legal and regulatory 

requirements. 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: January 2, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–190 Filed 1–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA No. 225–07–8004] 

Memorandum of Understanding 

Between the Food and Drug 

Administration and Regents of the 

University of California 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between FDA and 


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1620 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices 

the University of California, Davis 

campus (UC Davis). The purpose of this 

MOU is to establish terms of 

collaboration between FDA and UC 

Davis, focused primarily but not 

exclusively, in the areas of the safety 

and security of foods and cosmetics, 

animal feeds and veterinary products. 

Beyond the collaborations in the 

traditional academic programs for 

training, research and outreach, this 

MOU will also include UC Davis 

extended partnerships such as the 

Western Institute for Food Safety and 

Security, and the Center for Produce 

Safety. 

DATES: The agreement became effective 

December 7, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Mary I. Poos, Officeof the 

Commissioner, Office of the Chief 

Medical Officer (HF–40), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–2825. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU. 

Dated: December 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S 


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[FR Doc. 08–30 Filed 1–8–08; 8:45 am] 

BILLING CODE 4160–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Patient Oriented and Career Enhancement 

Awards for Stem Cell Research. 

Date: February 20–21, 2008. 

Time: 8 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard Marriott, 2899 Jefferson 

Davis Highway, Arlington, VA 22202. 

Contact Person: Mark Roltsch, PhD, 

Scientific Review Administrator, Review 

Branch/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7192, Bethesda, MD 20892–7924, 301–435–

0287, roltschm@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Pathobiology Program Project. 

Date: February 21, 2008. 

Time: 10 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Four Point Sheraton BWI, 7032 Elm 

Road, Baltimore, MD 21240. 

Contact Person: Charles Joyce, PhD, 

Scientific Review Administrator, Review 

Branch/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7196, Bethesda, MD 20892–7924, 301–435–

0288, cjoyce@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Coagulation Program Project. 

Date: February 22, 2008. 

Time: 10 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Four Point Sheraton BWI, 7032 Elm 

Road, Baltimore, MD 21240. 

Contact Person: Charles Joyce, PhD, 

Scientific Review Administrator, Review 

Branch/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7196, Bethesda, MD 20892–7924, 301–435–

0288, cjoyce@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Resource Related Research Project. 

Date: February 28, 2008. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Keary A Cope, PhD, 

Scientific Review Administrator, Review 

Branch/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7190, Bethesda, MD 20892–7924, 301–435–

2222, copeka@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: January 3, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 08–41 Filed 1–8–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 


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