80 FR 78747 - Determination That Vancomycin Hydrochloride Injection Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 242 (December 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 242 (December 17, 2015)
| Page Range | 78747-78748 | |
| FR Document | 2015-31689 |
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)] [Notices] [Pages 78747-78748] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31689] [[Page 78747]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-4667] Determination That Vancomycin Hydrochloride Injection Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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 or Agency) has determined that VANCOCIN (vancomycin hydrochloride (HCl)) injection, 500 milligrams (mg)/vial, 1 gram (g)/vial, 10 g/vial (``the VANCOCIN drug products''); VANCOLED (vancomycin HCl) injection, 500 mg/vial, 1 g/vial, 2 g/vial, 5 g/vial, and 10 g/vial (``the VANCOLED drug products''); and VANCOCIN HYDROCHLORIDE (vancomycin HCl) injection, 500 mg/vial and 1 g/vial (``the VANCOCIN HCl drug products'') (hereinafter collectively ``these Vancomycin HCl drug products''), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for these Vancomycin HCl drug products if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240- 402-4510, Robin.Fastenau@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 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 known generally as the ``Orange Book.'' Under FDA regulations, drugs are 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). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. The VANCOCIN drug products are the subject of ANDA 62-812 held by ANI Pharmaceuticals, Inc., and were initially approved on November 17, 1987. The VANCOLED drug products are the subject of ANDA 62-682 held by Eurohealth International S[agrave]rl and were initially approved on July 22, 1986. The VANCOCIN HCl drug products are the subject of ANDA 60-180 held by ANI Pharmaceuticals, Inc., and were initially approved on November 6, 1964. These Vancomycin HCl drug products are indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. They are indicated for penicillin-allergic patients; for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins; and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. They are indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. These Vancomycin HCl drug products are currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. Strides Arcolab Limited submitted a citizen petition dated May 18, 2009 (Docket No. FDA-2009-P-0242), under Sec. 10.30 (21 CFR 10.30), requesting that the Agency determine whether VANCOCIN (Vancomycin HCl) injection, 10 g/vial, was withdrawn from sale for reasons of safety or effectiveness. Although the citizen petition did not address the 500 mg/vial and 1 g/vial strengths, these strengths have also been discontinued. On our own initiative, we have also determined whether these strengths were withdrawn for safety or effectiveness reasons. Hospira submitted a citizen petition dated October 5, 2015 (Docket No. FDA-2015-P-3621), under Sec. 10.30, requesting that the Agency determine whether VANCOLED (vancomycin HCl) injection, 10 g bulk packaging, was withdrawn from sale for reasons of safety or effectiveness. Although the citizen petition did not address the 500 mg/vial, 1 g/vial, 2 g/vial, and 5 g/vial strengths, these strengths have also been discontinued. On our own initiative, we have also determined whether these strengths were withdrawn from sale for reasons of safety or effectiveness. In addition, the VANCOCIN HCl (Vancomycin HCl), injection, 500 mg/vial, and 1 g/vial drug products have been discontinued from sale and FDA has determined whether these drug products were withdrawn from the market for safety or effectiveness reasons. After considering the citizen petitions and reviewing Agency records and based on the information we have at this time, FDA has determined under Sec. 314.161 that these Vancomycin HCl drug products were not withdrawn for reasons of safety or effectiveness. The petitioners have identified no data or other information suggesting that these Vancomycin HCl drug products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of these Vancomycin HCl drug products from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list these Vancomycin HCl drug products in the ``Discontinued Drug Product List'' section of the Orange Book. The ``Discontinued Drug Product List'' delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to these Vancomycin HCl drug products may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will [[Page 78748]] advise ANDA applicants to submit such labeling. Dated: December 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31689 Filed 12-16-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices 78747
DEPARTMENT OF HEALTH AND 355(j)(7)), which requires FDA to petition did not address the 500 mg/vial
HUMAN SERVICES publish a list of all approved drugs. and 1 g/vial strengths, these strengths
FDA publishes this list as part of the have also been discontinued. On our
Food and Drug Administration ‘‘Approved Drug Products With own initiative, we have also determined
Therapeutic Equivalence Evaluations,’’ whether these strengths were
[Docket No. FDA–2015–N–4667]
which is known generally as the withdrawn for safety or effectiveness
Determination That Vancomycin ‘‘Orange Book.’’ Under FDA regulations, reasons. Hospira submitted a citizen
Hydrochloride Injection Drug Products, drugs are removed from the list if the petition dated October 5, 2015 (Docket
Were Not Withdrawn From Sale for Agency withdraws or suspends No. FDA–2015–P–3621), under § 10.30,
Reasons of Safety or Effectiveness approval of the drug’s NDA or ANDA requesting that the Agency determine
for reasons of safety or effectiveness or whether VANCOLED (vancomycin HCl)
AGENCY: Food and Drug Administration, if FDA determines that the listed drug injection, 10 g bulk packaging, was
HHS. was withdrawn from sale for reasons of withdrawn from sale for reasons of
ACTION: Notice. safety or effectiveness (21 CFR 314.162). safety or effectiveness. Although the
A person may petition the Agency to citizen petition did not address the 500
SUMMARY: The Food and Drug determine, or the Agency may mg/vial, 1 g/vial, 2 g/vial, and 5 g/vial
Administration (FDA or Agency) has determine on its own initiative, whether strengths, these strengths have also been
determined that VANCOCIN a listed drug was withdrawn from sale discontinued. On our own initiative, we
(vancomycin hydrochloride (HCl)) for reasons of safety or effectiveness. have also determined whether these
injection, 500 milligrams (mg)/vial, 1 This determination may be made at any strengths were withdrawn from sale for
gram (g)/vial, 10 g/vial (‘‘the time after the drug has been withdrawn reasons of safety or effectiveness. In
VANCOCIN drug products’’); from sale, but must be made prior to addition, the VANCOCIN HCl
VANCOLED (vancomycin HCl) approving an ANDA that refers to the (Vancomycin HCl), injection, 500 mg/
injection, 500 mg/vial, 1 g/vial, 2 g/vial, listed drug (§ 314.161 (21 CFR 314.161)). vial, and 1 g/vial drug products have
5 g/vial, and 10 g/vial (‘‘the VANCOLED FDA may not approve an ANDA that been discontinued from sale and FDA
drug products’’); and VANCOCIN does not refer to a listed drug. has determined whether these drug
HYDROCHLORIDE (vancomycin HCl) The VANCOCIN drug products are the products were withdrawn from the
injection, 500 mg/vial and 1 g/vial (‘‘the subject of ANDA 62–812 held by ANI market for safety or effectiveness
VANCOCIN HCl drug products’’) Pharmaceuticals, Inc., and were initially reasons.
(hereinafter collectively ‘‘these approved on November 17, 1987. The After considering the citizen petitions
Vancomycin HCl drug products’’), were VANCOLED drug products are the and reviewing Agency records and
not withdrawn from sale for reasons of subject of ANDA 62–682 held by based on the information we have at this
safety or effectiveness. This Eurohealth International Sàrl and were time, FDA has determined under
determination will allow FDA to initially approved on July 22, 1986. The § 314.161 that these Vancomycin HCl
approve abbreviated new drug VANCOCIN HCl drug products are the drug products were not withdrawn for
applications (ANDAs) for these subject of ANDA 60–180 held by ANI reasons of safety or effectiveness. The
Vancomycin HCl drug products if all Pharmaceuticals, Inc., and were initially petitioners have identified no data or
other legal and regulatory requirements approved on November 6, 1964. These other information suggesting that these
are met. Vancomycin HCl drug products are Vancomycin HCl drug products were
indicated for the treatment of serious or withdrawn for reasons of safety or
FOR FURTHER INFORMATION CONTACT:
severe infections caused by susceptible effectiveness. We have carefully
Robin Fastenau, Center for Drug strains of methicillin-resistant (beta- reviewed our files for records
Evaluation and Research, Food and lactam-resistant) staphylococci. They concerning the withdrawal of these
Drug Administration, 10903 New are indicated for penicillin-allergic Vancomycin HCl drug products from
Hampshire Ave., Bldg. 51, Rm. 6236, patients; for patients who cannot receive sale. We have also independently
Silver Spring, MD 20993–0002, 240– or who have failed to respond to other evaluated relevant literature and data
402–4510, Robin.Fastenau@fda.hhs.gov. drugs, including the penicillins or for possible postmarketing adverse
SUPPLEMENTARY INFORMATION: In 1984, cephalosporins; and for infections events. We have reviewed the available
Congress enacted the Drug Price caused by vancomycin-susceptible evidence and determined that these
Competition and Patent Term organisms that are resistant to other drug products were not withdrawn from
Restoration Act of 1984 (Pub. L. 98–417) antimicrobial drugs. They are indicated sale for reasons of safety or
(the 1984 amendments), which for initial therapy when methicillin- effectiveness.
authorized the approval of duplicate resistant staphylococci are suspected, Accordingly, the Agency will
versions of drug products under an but after susceptibility data are continue to list these Vancomycin HCl
ANDA procedure. ANDA applicants available, therapy should be adjusted drug products in the ‘‘Discontinued
must, with certain exceptions, show that accordingly. Drug Product List’’ section of the Orange
the drug for which they are seeking These Vancomycin HCl drug products Book. The ‘‘Discontinued Drug Product
approval contains the same active are currently listed in the ‘‘Discontinued List’’ delineates, among other items,
ingredient in the same strength and Drug Product List’’ section of the Orange drug products that have been
dosage form as the ‘‘listed drug,’’ which Book. discontinued from marketing for reasons
is a version of the drug that was Strides Arcolab Limited submitted a other than safety or effectiveness.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
previously approved. ANDA applicants citizen petition dated May 18, 2009 ANDAs that refer to these Vancomycin
do not have to repeat the extensive (Docket No. FDA–2009–P–0242), under HCl drug products may be approved by
clinical testing otherwise necessary to § 10.30 (21 CFR 10.30), requesting that the Agency as long as they meet all
gain approval of a new drug application the Agency determine whether other legal and regulatory requirements
(NDA). VANCOCIN (Vancomycin HCl) for the approval of ANDAs. If FDA
The 1984 amendments include what injection, 10 g/vial, was withdrawn determines that labeling for these drug
is now section 505(j)(7) of the Federal from sale for reasons of safety or products should be revised to meet
Food, Drug, and Cosmetic Act (21 U.S.C. effectiveness. Although the citizen current standards, the Agency will
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![78748 Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
advise ANDA applicants to submit such instruments, email paperwork@hrsa.gov proposed data collection is to analyze
labeling. or call the HRSA Information Collection and report grantee training activities
Dated: December 11, 2015. Clearance Officer at (301) 443–1984. and education, identify intended
Leslie Kux, SUPPLEMENTARY INFORMATION: When practice locations and report outcomes
submitting comments or requesting of funded initiatives. Data collected
Associate Commissioner for Policy.
information, please include the from these grant programs will also
[FR Doc. 2015–31689 Filed 12–16–15; 8:45 am]
information request collection title for provide a description of the program
BILLING CODE 4164–01–P activities of approximately 1,700
reference.
reporting grantees to better inform
Information Collection Request Title: policymakers on the barriers,
DEPARTMENT OF HEALTH AND Bureau of Health Workforce opportunities, and outcomes involved
HUMAN SERVICES Performance Data Collection OMB No. in health care workforce development.
0915–0061—Revision The proposed measures focus on five
Health Resources and Services
Administration Abstract: Over 40 Bureau of Health key outcomes: (1) Increasing the
Workforce (BHW) programs award workforce supply of diverse well-
Agency Information Collection grants to health professions schools and educated practitioners, (2) increasing
Activities: Proposed Collection: Public training programs across the United the number of practitioners that practice
Comment Request States to develop, expand, and enhance in underserved and rural areas, (3)
training, and to strengthen the enhancing the quality of education, (4)
AGENCY: Health Resources and Services distribution of the health workforce. increasing the recruitment, training, and
Administration, HHS. These programs are authorized by the placement of under-represented groups
ACTION: Notice. Public Health Service Act (42 U.S.C. 201 in the health workforce, and (5)
et seq.), specifically Titles III, VII, and supporting educational infrastructure to
SUMMARY: In compliance with the increase the capacity to train more
VIII. Performance information regarding
requirement for opportunity for public health professionals.
these programs is collected in the HRSA
comment on proposed data collection
Performance Report for Grants and Likely Respondents: Respondents are
projects (Section 3506(c)(2)(A) of the
Cooperative Agreements (PRGCA). Data awardees of BHW health professions
Paperwork Reduction Act of 1995), the
collection activities consisting of an grant programs.
Health Resources and Services
annual progress and annual Burden Statement: Burden in this
Administration (HRSA) announces
performance report satisfy statutory and context means the time expended by
plans to submit an Information
programmatic requirements for persons to generate, maintain, retain,
Collection Request (ICR), described
performance measurement and disclose or provide the information
below, to the Office of Management and
evaluation (including specific Title III, requested. This includes the time
Budget (OMB). Prior to submitting the
VII and VIII requirements), as well as needed to review instructions; to
ICR to OMB, HRSA seeks comments
Government Performance and Results develop, acquire, install and utilize
from the public regarding the burden
Act (GPRA) requirements. The technology and systems for the purpose
estimate, below, or any other aspect of
performance measures were last revised of collecting, validating and verifying
the ICR.
in 2013 to ensure they addressed information, processing and
DATES: Comments on this Information programmatic changes, met evolving maintaining information, and disclosing
Collection Request must be received no program management needs, and and providing information; to train
later than February 16, 2016. responded to emerging workforce personnel and to be able to respond to
ADDRESSES: Submit your comments to concerns—especially as a result of the a collection of information; to search
paperwork@hrsa.gov or mail the HRSA changes in the Affordable Care Act (Pub. data sources; to complete and review
Information Collection Clearance L. 111–148). As these revisions were the collection of information; and to
Officer, Room 10–105, Parklawn successful, BHW will continue with its transmit or otherwise disclose the
Building, 5600 Fishers Lane, Rockville, current performance management information. The total annual burden
MD 20857. strategy and measures and require hours estimated for this Information
FOR FURTHER INFORMATION CONTACT: To annual progress and performance Collection Request are summarized in
request more information on the reporting. the table below.
proposed project or to obtain a copy of Need and Proposed Use of the Total Estimated Annualized burden
the data collection plans and draft Information: The purpose of the hours:
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Program Aggregate Data Collection* .................................. 600 1 600 6 3,600
Individual-level Data Collection ............................................ 1,100 1 1,100 2 2,200
Total .............................................................................. 1,700 ........................ 1,700 ........................ 5,800
asabaliauskas on DSK5VPTVN1PROD with NOTICES
* Program aggregate data collection will only be required for programs that do not provide direct financial support to all trainees.
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Document Created: 2018-03-02 09:17:45
Document Modified: 2018-03-02 09:17:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Robin Fastenau, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240- 402-4510, [email protected] | |
| FR Citation | 80 FR 78747 |
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