Determination of Regulatory Review Period for Purposes of Patent Extension; INSPRA, 34944-34945 [E6-9412]
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34944
Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
Application No.
Drug
Applicant
ANDA 84–015
Bleph–10 (sulfacetamide sodium ophthalmic ointment
USP) Ophthalmic Ointment, 10%
Allergan, Inc.
ANDA 84–514
Dilor (dyphylline tablets USP), 200 mg
Savage Laboratories
ANDA 84–751
Dilor–400 (dyphylline tablets USP), 400 mg
Do.
ANDA 85–035
Diphenoxylate HCl and Atropine Sulfate Tablets USP,
2.5 mg and 0.025 mg
R & S Pharma, LLC, 8407 Austin Tracy Rd., Fountain Run, KY
42133
ANDA 85–961
Methocarbamol Tablets USP, 500 mg
Clonmel Healthcare Ltd., c/o STADA Pharmaceuticals, Inc., U.S.
Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512
ANDA 85–963
Methocarbomal Tablets USP, 750 mg
Do.
ANDA 86–899
Isoetharine HCl Inhalation Solution USP, 1%
Roxane Laboratories, Inc.
ANDA 87–450
Chlorthalidone Tablets USP, 50 mg
Clonmel Healthcare Ltd.
ANDA 87–451
Chlorthalidone Tablets USP, 25 mg
Do.
ANDA 87–500
Aminophylline Tablets USP, 100 mg
Roxane Laboratories, Inc.
ANDA 87–501
Aminophylline Tablets USP, 200 mg
Do.
ANDA 88–253
T-Phyl (theophylline) Extended-Release Tablets, 200 mg
The Purdue Frederick Co.
Therefore, under section 505(e), of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(e)), and under authority
delegated to the Director, Center for
Drug Evaluation and Research, by the
Commissioner of Food and Drugs,
approval of the applications listed in the
table in this document, and all
amendments and supplements thereto,
is hereby withdrawn, effective June 16,
2006.
Dated: May 23, 2006.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E6–9440 Filed 6–15–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E–0254]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; INSPRA
AGENCY:
Food and Drug Administration,
HHS.
wwhite on PROD1PC61 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for INSPRA
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,
VerDate Aug<31>2005
18:25 Jun 15, 2006
Jkt 208001
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:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
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 human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the 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 INSPRA
(eplerenone). INSPRA is indicated for
the treatment of hypertension.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for INSPRA
(U.S. Patent No. 4,559,332) from
Novartis Corp., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated June 16, 2003, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of INSPRA
represented the first permitted
commercial marketing or use of the
product. Shortly 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
E:\FR\FM\16JNN1.SGM
16JNN1
wwhite on PROD1PC61 with NOTICES
Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
INSPRA is 2,135 days. Of this time,
1,832 days occurred during the testing
phase of the regulatory review period,
while 303 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) became effective: November 24,
1996. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on November 24, 1996.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: November 29, 2001.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Inspra (NDA 21–437) was initially
submitted on November 29, 2001.
3. The date the application was
approved: September 27, 2002. FDA has
verified the applicant’s claim that NDA
21–437 was approved on September 27,
2002.
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 1,218 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 August 15, 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
December 13, 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.
VerDate Aug<31>2005
18:25 Jun 15, 2006
Jkt 208001
Dated: May 17, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–9412 Filed 6–15–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0022]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SYMLIN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SYMLIN 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
which 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:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
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 human drug
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
34945
product 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 SYMLIN
(pramlintide acetate). SYMLIN is given
at mealtimes and is indicated for Type
1 diabetes, as an adjunct treatment in
patients who use mealtime insulin
therapy and who have failed to achieve
desired glucose control despite optimal
insulin therapy, and for Type 2 diabetes,
as an adjunct treatment in patients who
use mealtime insulin therapy and who
have failed to achieve desired glucose
control despite optimal insulin therapy,
with or without a concurrent
sulfonylurea agent and/or metformin.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for SYMLIN
(U.S. Patent No. 5,686,411) from Amylin
Pharmaceuticals, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated February 24, 2006, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of SYMLIN
represented the first permitted
commercial marketing or use of the
product. Shortly 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
SYMLIN is 4,620 days. Of this time,
3,060 days occurred during the testing
phase of the regulatory review period,
while 1,560 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: July 24, 1992.
The applicant claims July 29, 1992, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
E:\FR\FM\16JNN1.SGM
16JNN1
]]>Agencies
[Federal Register Volume 71, Number 116 (Friday, June 16, 2006)]
[Notices]
[Pages 34944-34945]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9412]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E-0254]
Determination of Regulatory Review Period for Purposes of Patent
Extension; INSPRA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for INSPRA 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: Beverly Friedman, Office of Regulatory
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2041.
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 human drug product 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 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 INSPRA
(eplerenone). INSPRA is indicated for the treatment of hypertension.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for INSPRA (U.S. Patent No.
4,559,332) from Novartis Corp., and the Patent and Trademark Office
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated June 16, 2003, FDA advised
the Patent and Trademark Office that this human drug product had
undergone a regulatory review period and that the approval of INSPRA
represented the first permitted commercial marketing or use of the
product. Shortly 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
[[Page 34945]]
INSPRA is 2,135 days. Of this time, 1,832 days occurred during the
testing phase of the regulatory review period, while 303 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) became effective:
November 24, 1996. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
November 24, 1996.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: November 29,
2001. FDA has verified the applicant's claim that the new drug
application (NDA) for Inspra (NDA 21-437) was initially submitted on
November 29, 2001.
3. The date the application was approved: September 27, 2002. FDA
has verified the applicant's claim that NDA 21-437 was approved on
September 27, 2002.
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 1,218 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 August 15, 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 December 13,
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: May 17, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-9412 Filed 6-15-06; 8:45 am]
BILLING CODE 4160-01-S
