80_FR_27412 80 FR 27320 - Determination That SODIUM SULAMYD (sulfacetamide sodium) Ophthalmic Solution and Ophthalmic Ointment Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

80 FR 27320 - Determination That SODIUM SULAMYD (sulfacetamide sodium) Ophthalmic Solution and Ophthalmic Ointment Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 92 (May 13, 2015)

Page Range27320-27321
FR Document2015-11529

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 these 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.

Federal Register, Volume 80 Issue 92 (Wednesday, May 13, 2015) 
[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27320-27321]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11529]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1339]


Determination That SODIUM SULAMYD (sulfacetamide sodium) 
Ophthalmic Solution and Ophthalmic Ointment Were Not Withdrawn From 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 or Agency) has 
determined that the 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withdrawn from sale for reasons of safety or effectiveness.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 
these 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: Amy Hopkins, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993-0002, 301-
796-5418, Amy.Hopkins@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
applicants 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. ANDA applicants do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic 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, a drug is removed 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, (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved, and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn 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. (As requested by the 
applicant, FDA withdrew approval of NDA 005963 for SODIUM SULAMYD 
(sulfacetamide sodium) Ophthalmic Solution and Ophthalmic Ointment in 
the Federal Register of August 16, 2001 (66 FR 43017)).

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 005963..................  SODIUM SULAMYD        Schering Plough
                               (sulfacetamide        Corp., 2000
                               sodium) Ophthalmic    Galloping Hill Rd.,
                               Solution 10%,         Kenilworth, NJ
                               Ophthalmic Solution   07033.
                               30%, and Ophthalmic
                               Ointment 10%.
------------------------------------------------------------------------

    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 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.

[[Page 27321]]

    Approved ANDAs that refer to the NDA listed in this document are 
unaffected by the discontinued marketing of the products subject to 
this NDA. Additional ANDAs that refer to these 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: May 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11529 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P

27320 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices practices regulation (21 CFR 10.115). Dated: May 7, 2015. contains the same active ingredient in The draft guidance, when finalized, will Leslie Kux, the same strength and dosage form as represent the current thinking of FDA Associate Commissioner for Policy. the ‘‘listed drug,’’ which is a version of on nonclinical assessment of [FR Doc. 2015–11539 Filed 5–12–15; 8:45 am] the drug that was previously approved. investigational ERT products. It does BILLING CODE 4164–01–P ANDA applicants do not have to repeat not establish any rights for any person the extensive clinical testing otherwise and is not binding on FDA or the public. necessary to gain approval of a new You can use an alternative approach if DEPARTMENT OF HEALTH AND drug application (NDA). it satisfies the requirements of the HUMAN SERVICES The 1984 amendments include what applicable statutes and regulations. is now section 505(j)(7) of the Federal Food and Drug Administration Food, Drug, and Cosmetic Act (21 U.S.C. II. The Paperwork Reduction Act of [Docket No. FDA–2015–N–1339] 355(j)(7)), which requires FDA to 1995 publish a list of all approved drugs. Determination That SODIUM SULAMYD FDA publishes this list as part of the This guidance refers to previously (sulfacetamide sodium) Ophthalmic ‘‘Approved Drug Products with approved collections of information that Solution and Ophthalmic Ointment Therapeutic Equivalence Evaluations,’’ are subject to review by the Office of Were Not Withdrawn From Sale for which is generally known as the Management and Budget (OMB) under Reasons of Safety or Effectiveness ‘‘Orange Book.’’ Under FDA regulations, the Paperwork Reduction Act of 1995 a drug is removed from the list if the (44 U.S.C. 3501–3520). The collections AGENCY: Food and Drug Administration, HHS. Agency withdraws or suspends of information in 21 CFR part 312 have approval of the drug’s NDA or ANDA been approved under OMB control ACTION: Notice. for reasons of safety or effectiveness or number 0910–0014, and the information SUMMARY: The Food and Drug if FDA determines that the listed drug collection in the regulations on good Administration (FDA or Agency) has was withdrawn from sale for reasons of laboratory practice for nonclinical determined that the drug products listed safety or effectiveness (21 CFR 314.162). laboratory studies (21 CFR part 58) is in this document were not withdrawn Under § 314.161(a) (21 CFR approved under OMB control number from sale for reasons of safety or 314.161(a)), the Agency must determine 0910–0119. effectiveness. This determination means whether a listed drug was withdrawn that FDA will not begin procedures to from sale for reasons of safety or III. Comments withdraw approval of abbreviated new effectiveness: (1) Before an ANDA that Interested persons may submit either drug applications (ANDAs) that refer to refers to that listed drug may be electronic comments regarding this these drug products, and it will allow approved, (2) whenever a listed drug is FDA to continue to approve ANDAs that voluntarily withdrawn from sale and document to http://www.regulations.gov refer to the products as long as they ANDAs that refer to the listed drug have or written comments to the Division of meet relevant legal and regulatory been approved, and (3) when a person Dockets Management (see ADDRESSES). It requirements. is only necessary to send one set of petitions for such a determination under comments. Identify comments with the FOR FURTHER INFORMATION CONTACT: 21 CFR 10.25(a) and 10.30. Section docket number found in brackets in the Amy Hopkins, Center for Drug 314.161(d) provides that if FDA Evaluation and Research, Food and determines that a listed drug was heading of this document. Received Drug Administration, 10903 New withdrawn from sale for safety or comments may be seen in the Division Hampshire Ave., Bldg. 51, Rm. 6223, effectiveness reasons, the Agency will of Dockets Management between 9 a.m. initiate proceedings that could result in Silver Spring, MD 20993–0002, 301– and 4 p.m., Monday through Friday, and the withdrawal of approval of the 796–5418, Amy.Hopkins@fda.hhs.gov. will be posted to the docket at http:// ANDAs that refer to the listed drug. SUPPLEMENTARY INFORMATION: In 1984, www.regulations.gov. Congress enacted the Drug Price FDA has become aware that the drug IV. Electronic Access Competition and Patent Term products listed in the table in this Restoration Act of 1984 (Pub. L. 98–417) document are no longer being marketed. Persons with access to the Internet (the 1984 amendments), which (As requested by the applicant, FDA may obtain the document at either authorized the approval of duplicate withdrew approval of NDA 005963 for http://www.fda.gov/Drugs/Guidance versions of drug products approved SODIUM SULAMYD (sulfacetamide ComplianceRegulatoryInformation/ under an ANDA procedure. ANDA sodium) Ophthalmic Solution and Guidances/default.htm or http:// applicants must, with certain Ophthalmic Ointment in the Federal www.regulations.gov. exceptions, show that the drug for Register of August 16, 2001 (66 FR which they are seeking approval 43017)). Application No. Drug Applicant NDA 005963 ........................ SODIUM SULAMYD (sulfacetamide sodium) Oph- Schering Plough Corp., 2000 Galloping Hill Rd., Ken- thalmic Solution 10%, Ophthalmic Solution 30%, and ilworth, NJ 07033. Ophthalmic Ointment 10%. asabaliauskas on DSK5VPTVN1PROD with NOTICES FDA has reviewed its records and, effectiveness. Accordingly, the Agency ‘‘Discontinued Drug Product List’’ under § 314.161, has determined that will continue to list the drug products identifies, among other items, drug the drug products listed in this listed in this document in the products that have been discontinued document were not withdrawn from ‘‘Discontinued Drug Product List’’ from marketing for reasons other than sale for reasons of safety or section of the Orange Book. The safety or effectiveness. VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\13MYN1.SGM 13MYN1

Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27321 Approved ANDAs that refer to the Dated: May 6, 2015. MD 20993–0002. Send one self- NDA listed in this document are Leslie Kux, addressed adhesive label to assist that unaffected by the discontinued Associate Commissioner for Policy. office in processing your requests. See marketing of the products subject to this [FR Doc. 2015–11526 Filed 5–12–15; 8:45 am] the SUPPLEMENTARY INFORMATION section NDA. Additional ANDAs that refer to BILLING CODE 4164–01–P for electronic access to the draft these products may also be approved by guidance document. the Agency if they comply with relevant Submit electronic comments on the legal and regulatory requirements. If DEPARTMENT OF HEALTH AND draft guidance to http:// FDA determines that labeling for these HUMAN SERVICES www.regulations.gov. Submit written drug products should be revised to meet comments to the Division of Dockets current standards, the Agency will Food and Drug Administration Management (HFA–305), Food and Drug advise ANDA applicants to submit such Administration, 5630 Fishers Lane, Rm. [Docket No. FDA–2011–D–0611] labeling. 1061, Rockville, MD 20852. Dated: May 7, 2015. Biosimilars: Additional Questions and FOR FURTHER INFORMATION CONTACT: Leslie Kux, Answers Regarding Implementation of Sandra Benton, Center for Drug Associate Commissioner for Policy. the Biologics Price Competition and Evaluation and Research, Food and [FR Doc. 2015–11529 Filed 5–12–15; 8:45 am] Innovation Act of 2009; Draft Guidance Drug Administration, 10903 New for Industry; Availability Hampshire Ave., Bldg. 51, Rm. 6340, BILLING CODE 4164–01–P Silver Spring, MD 20993–0002, 301– AGENCY: Food and Drug Administration, 796–1042, or Stephen Ripley, Center for HHS. Biologics Evaluation and Research, DEPARTMENT OF HEALTH AND ACTION: Notice. Food and Drug Administration, 10903 HUMAN SERVICES New Hampshire Ave., Bldg. 71, Rm. SUMMARY: The Food and Drug 7301, Silver Spring, MD 20993–0002, Food and Drug Administration Administration (FDA or Agency) is 240–402–7911. announcing the availability of a revised [Docket No. FDA–2008–N–0312] SUPPLEMENTARY INFORMATION: draft guidance for industry entitled ‘‘Biosimilars: Additional Questions and I. Background Agency Information Collection Answers Regarding Implementation of Activities; Announcement of Office of FDA is announcing the availability of the Biologics Price Competition and a revised draft guidance for industry Management and Budget Approval; Innovation Act of 2009.’’ This draft Extra Label Drug Use in Animals entitled ‘‘Biosimilars: Additional guidance is intended to provide answers Questions and Answers Regarding AGENCY: Food and Drug Administration, to common questions from sponsors Implementation of the Biologics Price HHS. interested in developing proposed Competition and Innovation Act of biosimilar products, biologics license 2009.’’ This draft guidance provides ACTION: Notice. application (BLA) holders, and other answers to common questions from interested parties regarding FDA’s sponsors interested in developing SUMMARY: The Food and Drug interpretation of the Biologics Price proposed biosimilar products, BLA Administration (FDA) is announcing Competition and Innovation Act of 2009 holders, and other interested parties that a collection of information entitled, (BPCI Act). This guidance revises the regarding FDA’s interpretation of the ‘‘Extra Label Drug Use in Animals’’ has draft guidance entitled ‘‘Biosimilars: BPCI Act. This guidance revises the been approved by the Office of Questions and Answers Regarding draft guidance entitled ‘‘Biosimilars: Management and Budget (OMB) under Implementation of the Biologics Price Questions and Answers Regarding the Paperwork Reduction Act of 1995. Competition and Innovation Act of Implementation of the Biologics Price FOR FURTHER INFORMATION CONTACT: FDA 2009,’’ issued February 15, 2012, to PRA Staff, Office of Operations, Food Competition and Innovation Act of provide new and revised questions and 2009,’’ issued February 15, 2012, to and Drug Administration, 8455 answers (Q&As). Colesville Rd., COLE–14526, Silver provide new and revised Q&As. It also DATES: Although you can comment on includes certain original Q&As that have Spring, MD 20993–0002, PRAStaff@ any guidance at any time (see 21 CFR fda.hhs.gov. not yet been finalized. 10.115(g)(5)), to ensure that the Agency The BPCI Act, enacted as part of the SUPPLEMENTARY INFORMATION: On considers your comment on this draft Patient Protection and Affordable Care February 18, 2015, the Agency guidance before it begins work on the Act (Pub. L. 111–148) on March 23, submitted a proposed collection of final version of the guidance, submit 2010, created an abbreviated licensure information entitled, ‘‘Extra Label Drug either electronic or written comments pathway under section 351(k) of the Use in Animals’’ to OMB for review and on the draft guidance by July 13, 2015. Public Health Service Act (the PHS Act) clearance under 44 U.S.C. 3507. An ADDRESSES: Submit written requests for (42 U.S.C. 262(k)) for biological Agency may not conduct or sponsor, single copies of the draft guidance to the products demonstrated to be biosimilar and a person is not required to respond Division of Drug Information, Center for to, or interchangeable with, an FDA- to, a collection of information unless it Drug Evaluation and Research, Food licensed reference product. This draft displays a currently valid OMB control and Drug Administration, 10001 New guidance describes FDA’s current asabaliauskas on DSK5VPTVN1PROD with NOTICES number. OMB has now approved the Hampshire Ave., Hillandale Building, interpretation of certain statutory information collection and has assigned 4th Floor, Silver Spring, MD 20993– requirements added by the BPCI Act OMB control number 0910–0325. The 0002, or Office of Communication, and includes Q&As in the following approval expires on March 31, 2018. A Outreach and Development (HFM–40), categories: copy of the supporting statement for this Center for Biologics Evaluation and • Biosimilarity or Interchangeability information collection is available on Research (CBER), Food and Drug • Provisions Related to Requirement the Internet at http://www.reginfo.gov/ Administration, 10903 New Hampshire to Submit a BLA for a ‘‘Biological public/do/PRAMain. Ave., Bldg. 71, Rm. 3128, Silver Spring, Product’’ VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\13MYN1.SGM 13MYN1


Document Created: 2015-12-16 07:47:22
Document Modified: 2015-12-16 07:47:22
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactAmy Hopkins, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993-0002, 301- 796-5418, [email protected]
FR Citation80 FR 27320 
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