5668 Federal Register / Vol. 71, No. 22 / Thursday, February 2, 2006 / Notices 

CLARITIN Hives Relief. FDA approved 

this trade name and indication for OTC 

use under NDA 20–641 on November 

19, 2003. Schering has not marketed the 

5-mg/5-mL strength of Claritin Hives 

Relief syrup. 

In a citizen petition dated February 

23, 2005 (Docket No. 2005P–0096), 

submitted under 21 CFR 10.30, Silarx 

Pharmaceuticals, Inc. (Silarx), requested 

that the agency determine, as described 

in § 314.161, whether CLARITIN 

(loratadine) Hives Relief syrup, 5 mg/5 

mL, was withdrawn from sale for 

reasons of safety or effectiveness. The 

agency has determined that Schering’s 

CLARITIN (loratadine) Hives Relief 

syrup, 5 mg/5 mL, approved under NDA 

20–641, was not withdrawn from sale 

for reasons of safety or effectiveness. To 

date, Schering has not marketed the 5- 

mg/5-mL strength of its CLARITIN 

(loratadine) Hives Relief syrup. In 

previous instances (see e.g., the Federal 

Register of December 30, 2002 (67 FR 

79640 at 79641) (addressing a relisting 

request for Diazepam Autoinjector)), 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. 

FDA has reviewed its files for records 

concerning the withdrawal of CLARITIN 

(loratadine) Hives Relief syrup, 5 mg/5 

mL. There is no indication that the 

decision not to market CLARITIN 

(loratadine) Hives Relief syrup, 5 mg/5 

mL, commercially is a function of safety 

or effectiveness concerns, and no data or 

information has been submitted to the 

docket concerning the reason for which 

CLARITIN (loratadine) Hives Relief 

syrup, 5 mg/5 mL was withdrawn from 

sale. The identical formulation and 

strength is currently marketed OTC as 

Claritin syrup for the temporary relief of 

symptoms due to hay fever or other 

respiratory allergies: runny nose, 

sneezing, itching, watery eyes, and 

itching of the nose or throat. FDA is not 

aware of information that would 

indicate that Claritin Hives Relief syrup 

was withdrawn from sale for reasons of 

safety or effectiveness. 

For the reasons outlined in this 

document, FDA has determined that 

Schering’s CLARITIN (loratadine) Hives 

Relief syrup, 5 mg/5 mL, was not 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

agency will continue to list CLARITIN 

(loratadine) Hives Relief syrup, 5 mg/5 

mL, 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 and effectiveness. ANDAs that 

refer to CLARITIN (loratadine) Hives 

Relief syrup, 5 mg/5 mL, may be 

approved by the agency. 

Dated: January 24, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–1364 Filed 2–1–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004E–0394] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ALOXI 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for ALOXI 

and is publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent that claims that 

human drug product. 

ADDRESSES: Submit written comments 

and petitions 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.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6681. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted, as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product ALOXI 

(palonosetron hydrochloride). ALOXI is 

indicated for the following: (1) The 

prevention of acute nausea and 

vomiting associated with initial or 

repeat courses of moderately and highly 

emetogenic cancer chemotherapy, and 

(2) the prevention of delayed nausea 

and vomiting associated with initial or 

repeat courses of moderately and highly 

emetogenic cancer chemotherapy. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for ALOXI 

(U.S. Patent No. 5,202,333) from Roche 

Palo Alto, LLC, and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated October 19, 2004, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of ALOXI 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the Patent and 

Trademark Office requested that FDA 

determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

ALOXI is 3,867 days. Of this time, 3,565 

days occurred during the testing phase 

of the regulatory review period, while 

302 days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption under 

section 505 of the Federal Food, Drug, 

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

355) became effective: December 24, 

1992. The applicant claims December 

22, 1992, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 


hsrobinson on PROD1PC71 with NOTICES
Federal Register / Vol. 71, No. 22 / Thursday, February 2, 2006 / Notices 5669 

indicate that the IND effective date was 

December 24, 1992, 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 

of the act: September 27, 2002. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) for ALOXI 

(NDA 21–372) was initially submitted 

on September 27, 2002. 

3. The date the application was 

approved: July 25, 2003. FDA has 

verified the applicant’s claim that NDA 

21–372 was approved on July 25, 2003. 

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 application for patent extension, 

this applicant seeks 1,827 days of patent 

term extension. 

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 April 3, 2006. 

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 

August 1, 2006. 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: January 5, 2006. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 06–903 Filed 2–1–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. 2005E–0258, 2005E–0247, and 

2005E–0233] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; OMACOR 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

OMACOR and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of three 

applications to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of three 

patents that claim that human drug 

product. 

ADDRESSES: Submit written comments 

and petitions 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.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6681. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted, as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product OMACOR 

(omega–3–acid ethyl esters). OMACOR 

is indicated as an adjunct to diet to 

reduce very high (= 500 milligrams per 

deciliter) triglyceride levels in adult 

patients. Subsequent to this approval, 

the Patent and Trademark Office 

received three patent term restoration 

applications for OMACOR (U.S. Patent 

Nos. 5,656,667, 5,698,594, and 

5,502,077) from Pronova Biocare AS, 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining these patents’ eligibility for 

patent term restoration. In a letter dated 

July 8, 2005, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of OMACOR represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

Patent and Trademark Office requested 

that FDA determine the product’s 

regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

OMACOR is 3,712 days. Of this time, 

3,408 days occurred during the testing 

phase of the regulatory review period, 

while 304 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

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: September 14, 

1994. The applicant claims August 15, 

1994, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was September 14, 

1994, 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 

of the act: January 12, 2004. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) for 

OMACOR (NDA 21–654) was initially 

submitted on January 12, 2004. 

3. The date the application was 

approved: November 10, 2004. FDA has 

verified the applicant’s claim that NDA 


hsrobinson on PROD1PC71 with NOTICES