Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices 22751 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(i)) became effective: June 21, 1998. 

The applicant claims June 19, 1998, as 

the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was June 21, 1998, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: September 8, 2003. 

The applicant claims September 5, 

2003, as the date the new drug 

application (NDA) for SENSIPAR (NDA 

21–688) was initially submitted. 

However, FDA records indicate that 

NDA 21–688 was submitted on 

September 8, 2003, which is considered 

to be the initially submitted date. 

3. The date the application was 

approved: March 8, 2004. FDA has 

verified the applicant’s claim that NDA 

21–688 was approved on March 8, 2004. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 449 days of patent 

term extension for U.S. Patent Nos. 

6,011,068 and 6,313,146, and 627 days 

of patent term extension for U.S. Patent 

No. 6,211,244. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by July 13, 2009. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

November 10, 2009. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: April 6, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research 

[FR Doc. E9–11219 Filed 5–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0188] 

Determination That DECADRON 

Tablets and Nine Other Drug Products 

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 the 10 drug products listed in this 

document 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 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Olivia Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6308, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

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. Sponsors of 

ANDAs 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 (the 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, 

a drug is withdrawn 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; (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved; and (3) when a person 

petitions for such a determination under 

21 CFR 10.25(a) and 10.30. Section 

314.161(d) provides that if FDA 

determines that a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness, the agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA has become aware that the drug 

products listed in the table in this 

document are no longer being marketed. 

(As requested by the applicant, FDA 

withdrew approval of NDA 18–821 for 

REGLAN (metoclopramide) Oral 

Solution in the Federal Register of 

October 10, 2002 (67 FR 63107).) 

Application No. Drug Applicant 

NDA 11–664 DECADRON (dexamethasone) Tablets, 0.5 

milligram (mg) and 0.75 mg 

Merck & Co., P.O. Box 4, BLA–20, West 

Point, PA 19486 

NDA 15–229 AMICAR (aminocaproic acid) Injection, 250 

mg/milliliter (mL) 

Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071–4563 


pwalker on PROD1PC71 with NOTICES
22752 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices 

Application No. Drug Applicant 

NDA 16–636 NARCAN (naloxone hydrocholoride (HCl)) Injection, 0.02 mg/mL, 0.4 mg/mL, and 1 mg/ 

mL 

Endo Pharmaceuticals, Inc., 100 Painters Dr., 

Chadds Ford, PA 19317 

NDA 16–929 FUDR (floxuridine) Injection, 500 mg/vial Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045 

NDA 18–538 LOZOL (indapamide) Tablets, 1.25 mg and 

2.5 mg 

Sanofi-Aventis U.S., 55 Corporate Blvd., P.O. 

Box 5925, Bridgewater, NJ 08807 

NDA 18–821 REGLAN (metaclopramide HCl) Oral Solution, equivalent to (EQ) 5 mg base/5 mL A.H. Robins Co., c/o Wyeth-Ayerst Research, 

P.O. Box 8299, Philadelphia, PA 19101– 

8299 

NDA 18–831 TRACRIUM (atracurium besylate) Injection, 

10 mg/mL 

Hospira, Inc. 

NDA 18–831 TRACRIUM (atracurium besylate) Preservative Free Injection, 10 mg/mL Do. 

NDA 19–080 PROSOM (estazolam) Tablets, 1 mg and 2 

mg 

Abbott Laboratories, 200 Abbott Park Rd., D– 

491, AP30–1E, Abbott Park, IL 60064– 

6157 

NDA 20–397 ZANAFLEX (tizanidine HCL) Tablets, EQ 2 

mg base 

Acorda Therapeutics, 15 Skyline Dr., Hawthorne, NY 10532 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the agency 

will continue to list the drug products 

listed in this document in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

NDAs listed in this document are 

unaffected by the discontinued 

marketing of the products subject to 

those NDAs. Additional ANDAs that 

refer to these products may also be 

approved by the agency if they comply 

with relevant legal and regulatory 

requirements. If FDA determines that 

labeling for these drug products should 

be revised to meet current standards, the 

agency will advise ANDA applicants to 

submit such labeling. 

Dated: May 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–11217 Filed 5–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0189] 

Guidance for Industry: Animal Generic 

Drug User Fees and Fee Waivers and 

Reductions; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document for 

industry (#199) entitled ‘‘Animal 

Generic Drug User Fees and Fee Waivers 

and Reductions.’’ The purpose of this 

document is to provide guidance to 

industry on the Animal Generic Drug 

User Fee Act of 2008 (AGDUFA). FDA 

is issuing this final guidance document 

for immediate implementation 

consistent with the agency’s good 

guidance practices (GGPs). Interested 

persons may submit comments on 

agency guidances at any time. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

to the Communications Staff (HFV–12), 

Center for Veterinary Medicine, Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

guidance document to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

David Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8307, email: dnewkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On August 14, 2008, AGDUFA (Public 

Law 110–316) was enacted. AGDUFA 

amends the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) and 

requires FDA to assess and collect user 

fees for certain applications, products, 

and sponsors. It also requires the agency 

to grant a waiver from or a reduction of 

fees in certain circumstances. Under 

section 741(d) of the FD&C Act, when 

certain conditions are met, FDA will 

waive or reduce fees for generic new 

animal drugs intended solely to provide 

for a minor use or minor species 

indication. 

The purpose of the guidance 

document is to provide guidance on the 

types of fees FDA is authorized to 

collect under AGDUFA and how to 

request waivers and reductions of these 

fees. It describes the types of fees, the 

type of fee waiver or reduction 


pwalker on PROD1PC71 with NOTICES