Determination of Regulatory Review Period for Purposes of Patent Extension; ALOXI, 5668-5669 [06-903]
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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mL, was withdrawn from sale for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20–641, was not withdrawn from sale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 5mg/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syrup, 5 mg/5 mL was withdrawn from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was withdrawn from sale for reasons of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withdrawn from sale for reasons of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
VerDate Aug<31>2005
15:26 Feb 01, 2006
Jkt 208001
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 https://
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
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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
E:\FR\FM\02FEN1.SGM
02FEN1
Federal Register / Vol. 71, No. 22 / Thursday, February 2, 2006 / Notices
hsrobinson on PROD1PC71 with NOTICES
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
VerDate Aug<31>2005
15:26 Feb 01, 2006
Jkt 208001
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.
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 https://
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.
ADDRESSES:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
5669
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
E:\FR\FM\02FEN1.SGM
02FEN1
]]>Agencies
[Federal Register Volume 71, Number 22 (Thursday, February 2, 2006)]
[Notices]
[Pages 5668-5669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-903]
-----------------------------------------------------------------------
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 https://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
[[Page 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
