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14118 Federal Register / Vol. 72, No.

57 / Monday, March 26, 2007 / Notices

Dated: March 20, 2007. FDA publishes this list as part of the postmarketing adverse events and has
Jeffrey Shuren, ‘‘Approved Drug Products With found no information that would
Assistant Commissioner for Policy. Therapeutic Equivalence Evaluations,’’ indicate that either DURICEF Tablets, 1
[FR Doc. E7–5470 Filed 3–23–07; 8:45 am] which is generally known as the g, or Capsules, 500 mg, were withdrawn
BILLING CODE 4160–01–S
‘‘Orange Book.’’ Under FDA regulations, from sale for reasons of safety or
drugs are withdrawn from the list if the effectiveness.
agency withdraws or suspends approval After considering the citizen petition
DEPARTMENT OF HEALTH AND of the drug’s NDA or ANDA for reasons and reviewing agency records, FDA
HUMAN SERVICES of safety or effectiveness, or if FDA determines that, for the reasons outlined
determines that the listed drug was in this document, DURICEF (cefadroxil
Food and Drug Administration withdrawn from sale for reasons of USP) Tablets, 1 g, and Capsules, 500 mg,
safety or effectiveness (21 CFR 314.162). were not withdrawn from sale for
[Docket No. 2006P–0255]
Under 21 CFR 314.161(a), the reasons of safety or effectiveness.
Determination That DURICEF circumstances under which the agency Accordingly, the agency will continue
(Cefadroxil USP) Tablets, 1 Gram, and must determine whether a listed drug to list DURICEF (cefadroxil USP)
Capsules, 500 Milligrams, Were Not was withdrawn from sale for reasons of Tablets, 1 g, and Capsules, 500 mg, in
Withdrawn From Sale for Reasons of safety or effectiveness include: (1) the ‘‘Discontinued Drug Product List’’
Safety or Effectiveness Before an ANDA that refers to that listed section of the Orange Book. The
drug may be approved and (2) whenever ‘‘Discontinued Drug Product List’’
AGENCY: Food and Drug Administration, a listed drug is voluntarily withdrawn delineates, among other items, drug
HHS. from sale, and ANDAs that refer to the products that have been discontinued
ACTION: Notice. listed drug have been approved. Section from marketing for reasons other than
314.161(d) provides that if FDA safety or effectiveness. Approved
SUMMARY: The Food and Drug determines that a listed drug was ANDAs that refer to DURICEF cefadroxil
Administration (FDA) has determined withdrawn from sale for safety or USP) Tablets, 1 g, and Capsules, 500 mg,
that DURICEF (cefadroxil USP) Tablets, effectiveness reasons, the agency will are unaffected by the withdrawal of
1 gram (g), and Capsules, 500 milligrams initiate proceedings that could result in these products from sale. ANDAs that
(mg), were not withdrawn from sale for the withdrawal of approval of the refer to cefadroxil USP (tablets, 1 g, and
reasons of safety or effectiveness. This ANDAs that refer to the listed drug. cefadroxil USP capsules, 500 mg, may
determination will allow FDA to FDA may not approve an ANDA that be approved by the agency as long as
continue to approve abbreviated new does not refer to a listed drug. they meet all relevant legal and
drug applications (ANDAs) for DURICEF (cefadroxil USP) Tablets, 1 regulatory requirements for the approval
cefadroxil USP tablets, 1 g, and g, and Capsules, 500 mg, are the subjects of ANDAs.
cefadroxil USP capsules, 500 mg. of approved NDA 50–528 and NDA 50–
512, respectively, held by Warner Dated: March 15, 2007.
FOR FURTHER INFORMATION CONTACT:
Chilcott, Inc. (Warner Chilcott). Jeffrey Shuren,
Mary Catchings, Center for Drug
Evaluation and Research (HFD–7), Food DURICEF is an antibiotic indicated to Assistant Commissioner for Policy.
and Drug Administration, 5600 Fishers treat infections of the urinary tract, skin, [FR Doc. E7–5415 Filed 3–23–07; 8:45 am]
Lane, Rockville, MD 20857, 301–594– throat, and tonsils, caused by specific BILLING CODE 4160–01–S
2041. bacteria, including streptococci,
staphylococci, and Escherichia coli.
SUPPLEMENTARY INFORMATION: In 1984, Warner Chilcott has informed FDA that DEPARTMENT OF HEALTH AND
Congress enacted the Drug Price DURICEF (cefadroxil USP) Tablets 1 g, HUMAN SERVICES
Competition and Patent Term and Capsules, 500 mg, have been
Restoration Act of 1984 (Public Law 98– withdrawn from sale. Food and Drug Administration
417) (the 1984 amendments), which In a citizen petition dated June 13, [Docket No. 2006E–0240]
authorized the approval of duplicate 2006 (Docket No. 2006P–0255/CP1),
versions of drug products approved submitted under 21 CFR 10.30, Orchid Determination of Regulatory Review
under an ANDA procedure. ANDA Healthcare (a division of Orchid Period for Purposes of Patent
sponsors must, with certain exceptions, Chemicals & Pharmaceuticals Ltd.) Extension; REVLIMID
show that the drug for which they are requested that the agency determine
seeking approval contains the same whether DURICEF (cefadroxil USP) AGENCY: Food and Drug Administration,
active ingredient in the same strength Tablets, 1 g, were withdrawn from sale HHS.
and dosage form as the ‘‘listed drug,’’ for reasons of safety or effectiveness. In ACTION: Notice.
which is typically a version of the drug addition, there are approved ANDAs
that was previously approved. Sponsors that refer to DURICEF (cefadroxil USP) SUMMARY: The Food and Drug
of ANDAs do not have to repeat the Tablets, 1 g, and Capsules, 500 mg. Administration (FDA) has determined
extensive clinical testing otherwise The agency has determined that the regulatory review period for
necessary to gain approval of a new Warner Chilcott’s DURICEF (cefadroxil REVLIMID and is publishing this notice
drug application (NDA). The only USP) Tablets, 1 g, and Capsules, 500 mg, of that determination as required by
clinical data required in an ANDA are were not withdrawn from sale for law. FDA has made the determination
data to show that the drug that is the reasons of safety or effectiveness. The because of the submission of an
subject of the ANDA is bioequivalent to petitioner identified no data or other application to the Director of Patents
cprice-sewell on PROD1PC66 with NOTICES

the listed drug. information suggesting that DURICEF and Trademarks, Department of
The 1984 amendments include what Tablets, 1 g, and Capsules, 500 mg, were Commerce, for the extension of a patent
is now section 505(j)(7) of the Federal withdrawn from sale for reasons of which claims that human drug product.
Food, Drug, and Cosmetics Act (21 safety or effectiveness. FDA has ADDRESSES: Submit written comments
U.S.C. 355(j)(7)), which requires FDA to independently evaluated relevant and petitions to the Division of Dockets
publish a list of all approved drugs. literature and data for possible Management (HFA–305), Food and Drug

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Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices 14119

Administration, 5630 Fishers Lane, rm. eligibility for patent term restoration. In pp. 41–42, 1984.) Petitions should be in
1061, Rockville, MD 20852. Submit a letter dated June 14, 2006, FDA the format specified in 21 CFR 10.30.
electronic comments to http:// advised the Patent and Trademark Comments and petitions should be
www.fda.gov/dockets/ecomments. Office that this human drug product had submitted to the Division of Dockets
FOR FURTHER INFORMATION CONTACT: undergone a regulatory review period Management. Three copies of any
Beverly Friedman, Office of Regulatory and that the approval of REVLIMID mailed information are to be submitted,
Policy (HFD–7), Food and Drug represented the first permitted except that individuals may submit one
Administration, 5600 Fishers Lane, commercial marketing or use of the copy. Comments are to be identified
Rockville, MD 20857, 301–594–2041. product. Shortly thereafter, the Patent with the docket number found in
SUPPLEMENTARY INFORMATION: The Drug
and Trademark Office requested that brackets in the heading of this
Price Competition and Patent Term FDA determine the product’s regulatory document.
review period. Comments and petitions may be seen
Restoration Act of 1984 (Public Law 98–
FDA has determined that the in the Division of Dockets Management
417) and the Generic Animal Drug and
applicable regulatory review period for between 9 a.m. and 4 p.m., Monday
Patent Term Restoration Act (Public
REVLIMID is 2,069 days. Of this time, through Friday.
Law 100–670) generally provide that a
1,804 days occurred during the testing Dated: March 12, 2007.
patent may be extended for a period of
phase of the regulatory review period,
up to 5 years so long as the patented Jane A. Axelrad,
while 265 days occurred during the
item (human drug product, animal drug approval phase. These periods of time Associate Director for Policy, Center for Drug
product, medical device, food additive, were derived from the following dates:
Evaluation and Research.
or color additive) was subject to 1. The date an exemption under [FR Doc. E7–5439 Filed 3–23–07; 8:45 am]
regulatory review by FDA before the section 505(i) of the Federal Food, Drug, BILLING CODE 4160–01–S
item was marketed. Under these acts, a and Cosmetic Act (the act) (21 U.S.C.
product’s regulatory review period 355(i)) became effective: April 30, 2000.
forms the basis for determining the The applicant claims May 1, 2000, as DEPARTMENT OF HEALTH AND
amount of extension an applicant may the date the investigational new drug HUMAN SERVICES
receive. application (IND) became effective.
A regulatory review period consists of Food and Drug Administration
However, FDA records indicate that the
two periods of time: A testing phase and IND effective date was April 30, 2000, [Docket No. 2006E–0034]
an approval phase. For human drug which was 30 days after FDA receipt of
products, the testing phase begins when the IND. Determination of Regulatory Review
the exemption to permit the clinical 2. The date the application was Period for Purposes of Patent
investigations of the human drug initially submitted with respect to the Extension; PREVICOX
product becomes effective and runs human drug product under section
until the approval phase begins. The AGENCY: Food and Drug Administration,
505(b) of the act: April 7, 2005. FDA has HHS.
approval phase starts with the initial verified the applicant’s claim that the
submission of an application to market ACTION: Notice.
new drug application (NDA) for
the human drug product and continues REVLIMID (NDA 21–880) was initially SUMMARY: The Food and Drug
until FDA grants permission to market submitted on April 7, 2005. Administration (FDA) has determined
the drug product. Although only a 3. The date the application was the regulatory review period for
portion of a regulatory review period approved: December 27, 2005. FDA has PREVICOX and is publishing this notice
may count toward the actual amount of verified the applicant’s claim that NDA of that determination as required by
extension that the Director of Patents 21–880 was approved on December 27, law. FDA has made the determination
and Trademarks may award (for 2005. because of the submission of an
example, half the testing phase must be This determination of the regulatory application to the Director of Patents
subtracted as well as any time that may review period establishes the maximum and Trademarks, Department of
have occurred before the patent was potential length of a patent extension. Commerce, for the extension of a patent
issued), FDA’s determination of the However, the U.S. Patent and which claims that animal drug product.
length of a regulatory review period for Trademark Office applies several
ADDRESSES: Submit written comments
a human drug product will include all statutory limitations in its calculations
and petitions to the Division of Dockets
of the testing phase and approval phase of the actual period for patent extension.
Management (HFA–305), Food and Drug
as specified in 35 U.S.C. 156(g)(1)(B). In its application for patent extension,
Administration, 5630 Fishers Lane, rm.
FDA recently approved for marketing this applicant seeks 1,166 days of patent
1061, Rockville, MD 20852. Submit
the human drug product REVLIMID term extension.
electronic comments to http://
(lenalidomide). REVLIMID is indicated Anyone with knowledge that any of
www.fda.gov/dockets/ecomments.
for treatment of patients with the dates as published are incorrect may
transfusion-dependent anemia due to submit to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
Low- or Intermediate-1-risk Management (see ADDRESSES) written or Beverly Friedman, Office of Regulatory
myelodysplastic syndromes associated electronic comments and ask for a Policy (HFD–007), Center for Drug
with a deletion 5q cytogenetic redetermination by May 25, 2007. Evaluation and Research, Food and
abnormality with or without additional Furthermore, any interested person may Drug Administration, 5600 Fishers
cytogenetic abnormalities. Subsequent petition FDA for a determination Lane, Rockville, MD 20857, 301–594–
to this approval, the Patent and regarding whether the applicant for 2041.
cprice-sewell on PROD1PC66 with NOTICES

Trademark Office received a patent term extension acted with due diligence SUPPLEMENTARY INFORMATION: The Drug
restoration application for REVLIMID during the regulatory review period by Price Competition and Patent Term
(U.S. Patent No. 5,635,517) from September 24, 2007. To meet its burden, Restoration Act of 1984 (Public Law 98–
Celgene Corp., and the Patent and the petition must contain sufficient facts 417) and the Generic Animal Drug and
Trademark Office requested FDA’s to merit an FDA investigation. (See H. Patent Term Restoration Act (Public
assistance in determining this patent’s Rept. 857, part 1, 98th Cong., 2d sess., Law 100–670) generally provide that a

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