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Federal Register / Vol. 71, No.

189 / Friday, September 29, 2006 / Notices 57545

DEPARTMENT OF HEALTH AND the product. Although only a portion of verified the applicant’s claim that NDA
HUMAN SERVICES a regulatory review period may count 21–723 was approved on December 30,
toward the actual amount of extension 2004.
Food and Drug Administration that the Director of Patents and This determination of the regulatory
Trademarks may award (for example, review period establishes the maximum
[Docket No. 2006E–0005]
half the testing phase must be potential length of a patent extension.
Determination of Regulatory Review subtracted as well as any time that may However, the U.S. Patent and
Period for Purposes of Patent have occurred before the patent was Trademark Office applies several
Extension; LYRICA (New Drug issued), FDA’s determination of the statutory limitations in its calculations
Application 21–723) length of a regulatory review period for of the actual period for patent extension.
a human drug product will include all In its application for patent extension,
AGENCY: Food and Drug Administration, of the testing phase and approval phase this applicant seeks 533 days of patent
HHS. as specified in 35 U.S.C. 156(g)(1)(B). term extension.
ACTION: Notice. FDA recently approved for marketing Anyone with knowledge that any of
the human drug product LYRICA (NDA the dates as published are incorrect may
SUMMARY: The Food and Drug 21–723) (pregabalin). LYRICA (NDA 21– submit to the Division of Dockets
Administration (FDA) has determined 723) is indicated for management of Management (see ADDRESSES) written or
the regulatory review period for LYRICA postherpetic neuralgia. Subsequent to electronic comments and ask for a
(new drug application (NDA) 21–723) this approval, the Patent and Trademark redetermination by November 28, 2006.
and is publishing this notice of that Office received a patent term restoration Furthermore, any interested person may
determination as required by law. FDA application for LYRICA (NDA 21–723) petition FDA for a determination
has made the determination because of (U.S. Patent No. 6,001,876) from regarding whether the applicant for
the submission of an application to the Warner-Lambert Company LLC, and the extension acted with due diligence
Director of Patents and Trademarks, Patent and Trademark Office requested during the regulatory review period by
Department of Commerce, for the FDA’s assistance in determining this March 28, 2007. To meet its burden, the
extension of a patent which claims that patent’s eligibility for patent term petition must contain sufficient facts to
human drug product. restoration. In a letter dated February merit an FDA investigation. (See H.
ADDRESSES: Submit written comments 24, 2006, FDA advised the Patent and Rept. 857, part 1, 98th Cong., 2d sess.,
and petitions to the Division of Dockets Trademark Office that this human drug pp. 41–42, 1984.) Petitions should be in
Management (HFA–305), Food and Drug product had undergone a regulatory the format specified in 21 CFR 10.30.
Administration, 5630 Fishers Lane, rm. review period and that the approval of Comments and petitions should be
1061, Rockville, MD 20852. Submit LYRICA (NDA 21–723) represented the submitted to the Division of Dockets
electronic comments to http:// first permitted commercial marketing or Management. Three copies of any
www.fda.gov/dockets/ecomments. use of the product. Shortly thereafter, mailed information are to be submitted,
FOR FURTHER INFORMATION CONTACT:
the Patent and Trademark Office except that individuals may submit one
Beverly Friedman, Office of Regulatory requested that FDA determine the copy. Comments are to be identified
product’s regulatory review period. with the docket number found in
Policy (HFD–007), Food and Drug
FDA has determined that the brackets in the heading of this
Administration, 5600 Fishers Lane,
applicable regulatory review period for document. Comments and petitions may
Rockville, MD 20857, 301–594–2041. LYRICA (NDA 21–723) is 3,279 days. Of be seen in the Division of Dockets
SUPPLEMENTARY INFORMATION: The Drug this time, 2,852 days occurred during Management between 9 a.m. and 4 p.m.,
Price Competition and Patent Term the testing phase of the regulatory Monday through Friday.
Restoration Act of 1984 (Public Law 98– review period, while 427 days occurred
417) and the Generic Animal Drug and Dated: September 15, 2006.
during the approval phase. These
Patent Term Restoration Act (Public Jane A. Axelrad,
periods of time were derived from the
Law 100–670) generally provide that a following dates: Associate Director for Policy, Center for Drug
patent may be extended for a period of Evaluation and Research.
1. The date an exemption under
up to 5 years so long as the patented section 505(i) of the Federal Food, Drug, [FR Doc. E6–15962 Filed 9–28–06; 8:45 am]
item (human drug product, animal drug and Cosmetic Act (the act) (21 U.S.C. BILLING CODE 4160–01–S
product, medical device, food additive, 355(i)) became effective: January 10,
or color additive) was subject to 1996. The applicant claims August 24,
regulatory review by FDA before the 1997, as the date the investigational new DEPARTMENT OF HEALTH AND
item was marketed. Under these acts, a drug application (IND) became effective. HUMAN SERVICES
product’s regulatory review period However, FDA records indicate that the Food and Drug Administration
forms the basis for determining the IND effective date was January 10, 1996,
amount of extension an applicant may which was 30 days after FDA receipt of [Docket No. 2004E–0425]
receive. the initial IND.
A regulatory review period consists of 2. The date the application was Determination of Regulatory Review
two periods of time: A testing phase and initially submitted with respect to the Period for Purposes of Patent
an approval phase. For human drug human drug product under section Extension; PLENAXIS
products, the testing phase begins when 505(b) of the act: October 31, 2003. The AGENCY: Food and Drug Administration,
the exemption to permit the clinical applicant claims October 30, 2003, as HHS.
investigations of the human drug the date the new drug application ACTION: Notice.
product becomes effective and runs (NDA) for LYRICA (NDA 21–723) was
jlentini on PROD1PC65 with NOTICES

until the approval phase begins. The initially submitted. However, FDA SUMMARY: The Food and Drug
approval phase starts with the initial records indicate that NDA 21–723 was Administration (FDA) has determined
submission of an application to market submitted on October 31, 2003. the regulatory review period for
the human drug product and continues 3. The date the application was PLENAXIS and is publishing this notice
until FDA grants permission to market approved: December 30, 2004. FDA has of that determination as required by

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57546 Federal Register / Vol. 71, No. 189 / Friday, September 29, 2006 / Notices

law. FDA has made the determination castration, and have one or more of the Management (see ADDRESSES) written or
because of the submission of an following: (1) Risk of neurological electronic comments and ask for a
application to the Director of Patents compromise due to metastases, (2) redetermination by November 28, 2006.
and Trademarks, Department of ureteral or bladder outlet obstruction Furthermore, any interested person may
Commerce, for the extension of a patent due to local encroachment or metastatic petition FDA for a determination
that claims that human drug product. disease, or (3) severe bone pain from regarding whether the applicant for
ADDRESSES: Submit written comments skeletal metastases persisting on extension acted with due diligence
and petitions to the Division of Dockets narcotic analgesia. Subsequent to this during the regulatory review period by
Management (HFA–305), Food and Drug approval, the Patent and Trademark March 28, 2007. To meet its burden, the
Administration, 5630 Fishers Lane, rm. Office received a patent term restoration petition must contain sufficient facts to
1061, Rockville, MD 20852. Submit application for PLENAXIS (U.S. Patent merit an FDA investigation. (See H.
electronic comments to http:// No. 5,843,901) from Praecis Rept. 857, part 1, 98th Cong., 2d sess.,
www.fda.gov/dockets/ecomments. Pharmaceuticals, Inc., and the Patent pp. 41–42, 1984.) Petitions should be in
FOR FURTHER INFORMATION CONTACT: and Trademark Office requested FDA’s the format specified in 21 CFR 10.30.
Beverly Friedman, Office of Regulatory assistance in determining this patent’s Comments and petitions should be
Policy (HFD–007), Food and Drug eligibility for patent term restoration. In submitted to the Division of Dockets
Administration, 5600 Fishers Lane, a letter dated October 19, 2004, FDA Management. Three copies of any
Rockville, MD 20857, 301–594–2041. advised the Patent and Trademark mailed information are to be submitted,
Office that this human drug product had except that individuals may submit one
SUPPLEMENTARY INFORMATION: The Drug
undergone a regulatory review period copy. Comments are to be identified
Price Competition and Patent Term and that the approval of PLENAXIS
Restoration Act of 1984 (Public Law 98– with the docket number found in
represented the first permitted brackets in the heading of this
417) and the Generic Animal Drug and commercial marketing or use of the
Patent Term Restoration Act (Public document. Comments and petitions may
product. Shortly thereafter, the Patent be seen in the Division of Dockets
Law 100–670) generally provide that a and Trademark Office requested that
patent may be extended for a period of Management between 9 a.m. and 4 p.m.,
FDA determine the product’s regulatory Monday through Friday.
up to 5 years so long as the patented review period.
item (human drug product, animal drug FDA has determined that the Dated: September 1, 2006.
product, medical device, food additive, applicable regulatory review period for Jane A. Axelrad,
or color additive) was subject to PLENAXIS is 2,566 days. Of this time, Associate Director for Policy,Center for Drug
regulatory review by FDA before the 1,487 days occurred during the testing Evaluation and Research.
item was marketed. Under these acts, a phase of the regulatory review period, [FR Doc. E6–15969 Filed 9–28–06; 8:45 am]
product’s regulatory review period while 1,079 days occurred during the BILLING CODE 4160–01–S
forms the basis for determining the approval phase. These periods of time
amount of extension an applicant may were derived from the following dates:
receive. 1. The date an exemption under DEPARTMENT OF HEALTH AND
A regulatory review period consists of section 505(i) of the Federal Food, Drug, HUMAN SERVICES
two periods of time: A testing phase and and Cosmetic Act (the act) (21 U.S.C.
an approval phase. For human drug 355(i)) became effective: November 17, Food and Drug Administration
products, the testing phase begins when 1996. FDA has verified the applicant’s [Docket No. 2005E–0253]
the exemption to permit the clinical claim that the date the investigational
investigations of the human drug new drug application became effective Determination of Regulatory Review
product becomes effective and runs was on November 17, 1996. Period for Purposes of Patent
until the approval phase begins. The 2. The date the application was Extension; TARCEVA
approval phase starts with the initial initially submitted with respect to the
submission of an application to market human drug product under section AGENCY: Food and Drug Administration,
the human drug product and continues 505(b) of the act: December 12, 2000. HHS.
until FDA grants permission to market FDA has verified the applicant’s claim ACTION: Notice.
the product. Although only a portion of that the new drug application (NDA) for SUMMARY: The Food and Drug
a regulatory review period may count Plenaxis (NDA 21–320) was initially
toward the actual amount of extension Administration (FDA) has determined
submitted on December 12, 2000. the regulatory review period for
that the Director of Patents and 3. The date the application was
Trademarks may award (for example, TARCEVA and is publishing this notice
approved: November 25, 2003. FDA has
half the testing phase must be of that determination as required by
verified the applicant’s claim that NDA
subtracted as well as any time that may law. FDA has made the determination
21–320 was approved on November 25,
have occurred before the patent was because of the submission of an
2003.
issued), FDA’s determination of the This determination of the regulatory application to the Director of Patents
length of a regulatory review period for review period establishes the maximum and Trademarks, Department of
a human drug product will include all potential length of a patent extension. Commerce, for the extension of a patent
of the testing phase and approval phase However, the U.S. Patent and which claims that human drug product.
as specified in 35 U.S.C. 156(g)(1)(B). Trademark Office applies several ADDRESSES: Submit written comments
FDA recently approved for marketing statutory limitations in its calculations and petitions to the Division of Dockets
the human drug product PLENAXIS of the actual period for patent extension. Management (HFA–305), Food and Drug
(abarelix). PLENAXIS is indicated for In its application for patent extension, Administration, 5630 Fishers Lane, rm.
jlentini on PROD1PC65 with NOTICES

the palliative treatment of men with this applicant seeks 725 days of patent 1061, Rockville, MD 20852. Submit
advanced symptomatic prostate cancer, term extension. electronic comments to http://
in whom luteinizing hormone releasing Anyone with knowledge that any of www.fda.gov/dockets/ecomments.
hormone agonist therapy is not the dates as published are incorrect may FOR FURTHER INFORMATION CONTACT:
appropriate and who refuse surgical submit to the Division of Dockets Beverly Friedman, Office of Regulatory

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