Determination That RELAFEN (Nabumetone) Tablets and Three Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 12453-12454 [E8-4469]

Download as PDF 12453 Federal Register / Vol. 73, No. 46 / Friday, March 7, 2008 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 210 and 211 Total 1There Annual Frequency per Response 285 285 Total Annual Responses 1 1 Hours per Response 285 285 Total Hours .25 .25 71.25 71.25 are no capital costs or operating and maintenance costs associated with this collection of information. withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved or (2) whenever a listed drug is voluntarily withdrawn from sale, and ANDAs that refer to the listed drug have been approved. Section 314.161(d) provides that if FDA determines that a listed drug was removed from sale for safety or effectiveness reasons, the agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table in this document are no longer being marketed. Drug Applicant 19–583 RELAFEN (nabumetone) Tablets, 500 milligrams (mg) and 750 mg GlaxoSmithKline (formerly SmithKlineBeecham), 2301 Renaissance Blvd., P.O. Box 161540, King of Prussia, PA 19406–2772 19–643 MEVACOR (lovastatin) Tablets, 10 mg Merck & Co., One Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889–0100 50–416 CORTISPORIN Ophthalmic Ointment (bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin B sulfate) 400 units/gram (g); 1 percent; equivalent to 3.5 mg base/g; 10,000 units/g Monarch Pharmaceuticals, Inc., 501 Fifth Street, Bristol, TN 37620 50–461 ANCEF (cefazolin sodium) Injection, 250 mg base/vial, 500 mg base/vial, 5 g base/vial GlaxoSmithKline Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. Dated: February 29, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–4474 Filed 3–6–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0130] Determination That RELAFEN (Nabumetone) Tablets and Three Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined that the four drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to sroberts on PROD1PC70 with NOTICES NDA No. FDA has reviewed its records and, under § 314.161, has determined that VerDate Aug<31>2005 18:46 Mar 06, 2008 Jkt 214001 the drug products listed in this document were not withdrawn from PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 sale for reasons of safety or effectiveness. Accordingly, the agency E:\FR\FM\07MRN1.SGM 07MRN1 12454 Federal Register / Vol. 73, No. 46 / Friday, March 7, 2008 / Notices will continue to list the drug products listed in this document in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs. Additional ANDAs for the products may also be approved by the agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. Dated: February 29, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–4469 Filed 3–6–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0142] Draft Guidance for Industry and Review Staff on Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Availability AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ‘‘Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route.’’ The draft guidance provides recommendations concerning development of safety profiles to support approval of reformulated drug products and products proposed for use by a route of administration for which the product was not previously approved. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit VerDate Aug<31>2005 18:46 Mar 06, 2008 Jkt 214001 written or electronic comments on the draft guidance by May 6, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance 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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Paul Brown, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5172, Silver Spring, MD 20993–0002, 301–796–0856. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and review staff entitled ‘‘Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route.’’ This draft guidance is intended for individuals or organizations and review staff in the Center for Drug Evaluation and Research involved in the development and review of new formulations of products containing previously approved drug substances and proposals for existing formulations to be used in a new route of administration. This draft guidance assumes that the drug substance has already been used in an approved drug product. It outlines the nonclinical information generally recommended to support the development of a new formulation containing a previously approved drug substance. This draft guidance also provides nonclinical evaluation information for formulations intended for use by new routes of administration even if there is no change in the composition of the formulation. Although this situation does not represent a reformulation, it is appropriate in this case to reevaluate the toxicity information using considerations outlined in the draft guidance. This draft guidance does not absolve the sponsor from providing complete nonclinical information for a drug product, either directly or through a PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 right of reference to such information or by relying on the finding of safety and effectiveness for a listed drug and establishing a clinical bridge to that listed drug. This draft guidance pertains to new formulations containing previously approved drug substances only and does not address the safety evaluation of excipients. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on the safety evaluation of reformulated drug products, including products intended for administration by an alternate route. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm or https://www.fda.gov/ ohrms/dockets/default.htm. Dated: February 29, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–4481 Filed 3–6–08; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\07MRN1.SGM 07MRN1

Agencies

[Federal Register Volume 73, Number 46 (Friday, March 7, 2008)]
[Notices]
[Pages 12453-12454]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4469]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0130]


Determination That RELAFEN (Nabumetone) Tablets and Three Other 
Drug Products Were Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined that the 
four drug products listed in this document were not withdrawn from sale 
for reasons of safety or effectiveness. This determination means that 
FDA will not begin procedures to withdraw approval of abbreviated new 
drug applications (ANDAs) that refer to the drug products, and it will 
allow FDA to continue to approve ANDAs that refer to the products as 
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. Sponsors of ANDAs do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA). The only clinical 
data required in an ANDA are data to show that the drug that is the 
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)), 
which requires FDA to publish a list of all approved drugs. FDA 
publishes this list as part of the ``Approved Drug Products With 
Therapeutic Equivalence Evaluations,'' which is generally known as the 
``Orange Book.'' Under FDA regulations, drugs are withdrawn from the 
list if the agency withdraws or suspends approval of the drug's NDA or 
ANDA for reasons of safety or effectiveness, or if FDA determines that 
the listed drug was withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved or (2) whenever a listed drug is voluntarily 
withdrawn from sale, and ANDAs that refer to the listed drug have been 
approved. Section 314.161(d) provides that if FDA determines that a 
listed drug was removed from sale for safety or effectiveness reasons, 
the agency will initiate proceedings that could result in the 
withdrawal of approval of the ANDAs that refer to the listed drug.
    FDA has become aware that the drug products listed in the table in 
this document are no longer being marketed.

------------------------------------------------------------------------
        NDA No.                    Drug                  Applicant
------------------------------------------------------------------------
19-583                   RELAFEN (nabumetone)     GlaxoSmithKline
                          Tablets, 500             (formerly
                          milligrams (mg) and      SmithKlineBeecham),
                          750 mg                   2301 Renaissance
                                                   Blvd., P.O. Box
                                                   161540,
                                                  King of Prussia, PA
                                                   19406-2772
------------------------------------------------------------------------
19-643                   MEVACOR (lovastatin)     Merck & Co., One Merck
                          Tablets, 10 mg           Dr., P.O. Box 100,
                                                   Whitehouse Station,
                                                   NJ 08889-0100
------------------------------------------------------------------------
50-416                   CORTISPORIN Ophthalmic   Monarch
                          Ointment (bacitracin     Pharmaceuticals,
                          zinc; hydrocortisone;    Inc., 501 Fifth
                          neomycin sulfate;        Street,
                          polymyxin B sulfate)    Bristol, TN 37620
                          400 units/gram (g); 1
                          percent; equivalent to
                          3.5 mg base/g; 10,000
                          units/g
------------------------------------------------------------------------
50-461                   ANCEF (cefazolin         GlaxoSmithKline
                          sodium) Injection, 250
                          mg base/vial, 500 mg
                          base/vial, 5 g base/
                          vial
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency

[[Page 12454]]

will continue to list the drug products listed in this document in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List'' identifies, among other items, drug 
products that have been discontinued from marketing for reasons other 
than safety or effectiveness.
    Approved ANDAs that refer to the NDAs listed in this document are 
unaffected by the discontinued marketing of the products subject to 
those NDAs. Additional ANDAs for the products may also be approved by 
the agency if they comply with relevant legal and regulatory 
requirements. If FDA determines that labeling for these drug products 
should be revised to meet current standards, the agency will advise 
ANDA applicants to submit such labeling.

    Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4469 Filed 3-6-08; 8:45 am]
BILLING CODE 4160-01-S

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