82 FR 22669 - Determination That CALCIJEX (Calcitriol) Injectable, 1 Microgram/Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 94 (May 17, 2017)

Page Range		22669-22670
FR Document		2017-09960

The Food and Drug Administration (FDA or Agency) has determined that the drug product listed in this document was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

Federal Register, Volume 82 Issue 94 (Wednesday, May 17, 2017)

[Federal Register Volume 82, Number 94 (Wednesday, May 17, 2017)]
[Notices]
[Pages 22669-22670]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-09960]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2364]

Determination That CALCIJEX (Calcitriol) Injectable, 1 Microgram/
Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for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 product listed in this document was 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withdrawn from sale for reasons of safety or effectiveness.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
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.

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.

[[Page 22670]]

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 product listed in the table in
this document is no longer being marketed.

--------------------------------------------------------------------------------------------------------------------------------------------------------
Application No. Drug name Active ingredient Strength(s) Dosage form/route Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 018874............ CALCIJEX.............. Calcitriol............ 1 microgram (mcg)/ Injectable; Injection............. AbbVie, Inc.
milliliter (mL); 2
mcg/mL.
--------------------------------------------------------------------------------------------------------------------------------------------------------

FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug product listed in this document was not
withdrawn from sale for reasons of safety or effectiveness.\1\
Accordingly, the Agency will continue to list the drug product 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.
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\1\ We have also determined that the previous CALCIJEX
formulation originally approved on September 25, 1986, and
superseded by the currently approved formulation was not withdrawn
for reasons of safety or effectiveness.
---------------------------------------------------------------------------

Approved ANDAs that refer to the NDA listed in this document are
unaffected by the discontinued marketing of the products subject to
that NDA. Additional ANDAs that refer to this product may also be
approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
This is not a significant regulatory action subject to Executive
Order 12866 and does not impose any additional burden on regulated
entities.

Dated: May 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09960 Filed 5-16-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 94 / Wednesday, May 17, 2017 / Notices 22669

Evaluation and Research, Food and TABLE 1—NEW DRAFT PRODUCT-SPE- Guidances/default.htm or https://
Drug Administration, 10903 New CIFIC GUIDANCES FOR DRUG PROD- www.regulations.gov.
Hampshire Ave., Bldg. 75, Rm. 4730, UCTS—Continued Dated: May 11, 2017.
Silver Spring, MD 20993–0002, 301– Anna K. Abram,
796–5850. Hydrocortisone
Hydrocortisone butyrate Deputy Commissioner for Policy, Planning,
SUPPLEMENTARY INFORMATION: Legislation, and Analysis.
Linagliptin; Metformin hydrochloride
I. Background Lorcaserin hydrochloride [FR Doc. 2017–09961 Filed 5–16–17; 8:45 am]
In the Federal Register of June 11, Methylnaltrexone bromide BILLING CODE 4164–01–P
Nitroglycerin
2010 (75 FR 33311), FDA announced the Nystatin; Triamcinolone acetonide (multiple
availability of a guidance for industry reference listed drugs)
entitled ‘‘Bioequivalence DEPARTMENT OF HEALTH AND
Oxymetazoline hydrochloride; Tetracaine hy- HUMAN SERVICES
Recommendations for Specific drochloride
Products’’ that explained the process Sofosbuvir; Velpatasvir Food and Drug Administration
that would be used to make product- Venetoclax
specific guidances available to the [Docket No. FDA–2017–N–2364]
public on FDA’s Web site at https:// III. Drug Products for Which Revised
www.fda.gov/Drugs/ Draft Product-Specific Guidances are Determination That CALCIJEX
GuidanceComplianceRegulatory Available (Calcitriol) Injectable, 1 Microgram/
Information/Guidances/default.htm. Milliliter and 2 Micrograms/Milliliter,
As described in that guidance, FDA FDA is announcing the availability of Was Not Withdrawn From Sale for
adopted this process as a means to revised draft product-specific guidances Reasons of Safety or Effectiveness
develop and disseminate product- for industry for drug products
containing the following active AGENCY: Food and Drug Administration,
specific guidances and provide a HHS.
meaningful opportunity for the public to ingredients:
ACTION: Notice.
consider and comment on those
guidances. Under that process, draft TABLE 2—REVISED DRAFT PRODUCT- SUMMARY: The Food and Drug
guidances are posted on FDA’s Web site SPECIFIC GUIDANCES FOR DRUG Administration (FDA or Agency) has
and announced periodically in the PRODUCTS determined that the drug product listed
Federal Register. The public is in this document was not withdrawn
encouraged to submit comments on Acamprosate calcium from sale for reasons of safety or
those recommendations within 60 days Apixaban effectiveness. This determination means
of their announcement in the Federal Bexarotene
Calcium acetate (multiple reference listed
that FDA will not begin procedures to
Register. FDA considers any comments withdraw approval of abbreviated new
drugs)
received and either publishes final Deferiprone drug applications (ANDAs) that refer to
guidances or publishes revised draft Dolutegravir sodium this drug product, and it will allow FDA
guidances for comment. Guidances were Emtricitabine; Tenofovir disoproxil fumarate to continue to approve ANDAs that refer
last announced in the Federal Register Fingolimod to the product as long as they meet
on December 23, 2016 (81 FR 94394). Lanthanum carbonate relevant legal and regulatory
This notice announces draft product- Nevirapine requirements.
specific guidances, either new or Phenytoin (multiple reference listed drugs)
Propafenone hydrochloride FOR FURTHER INFORMATION CONTACT:
revised, that are posted on FDA’s Web
Trospium chloride (multiple reference listed Stacy Kane, Center for Drug Evaluation
site.
drugs) and Research, Food and Drug
II. Drug Products for Which New Draft Administration, 10903 New Hampshire
Product-Specific Guidances are For a complete history of previously Ave., Bldg. 51, Rm. 6236, Silver Spring,
Available published Federal Register notices MD 20993–0002, 301–796–8363.
FDA is announcing the availability of related to product-specific guidances, go SUPPLEMENTARY INFORMATION: In 1984,
a new draft product-specific guidances to https://www.regulations.gov and Congress enacted the Drug Price
for industry for drug products enter Docket No. FDA–2007–D–0369. Competition and Patent Term
containing the following active These draft guidances are being Restoration Act of 1984 (Pub. L. 98–417)
ingredients: issued consistent with FDA’s good (the 1984 amendments), which
guidance practices regulation (21 CFR authorized the approval of duplicate
TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when versions of drug products approved
CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current under an ANDA procedure. ANDA
UCTS
thinking of FDA on, among other things, applicants must, with certain
the product-specific design of BE exceptions, show that the drug for
Acetylcysteine studies to support ANDAs. They do not which they are seeking approval
Amphetamine establish any rights for any person and contains the same active ingredient in
Aprepitant are not binding on FDA or the public. the same strength and dosage form as
Azelastine hydrochloride You can use an alternative approach if the ‘‘listed drug,’’ which is a version of
Bisacodyl; polyethylene glycol 3350; potas- it satisfies the requirements of the the drug that was previously approved.
nlaroche on DSK30NT082PROD with NOTICES

sium chloride; sodium bicarbonate; sodium applicable statutes and regulations. ANDA applicants do not have to repeat
chloride the extensive clinical testing otherwise
Carbidopa; levodopa IV. Electronic Access
Chlordiazepoxide hydrochloride; Clidinium necessary to gain approval of a new
bromide
Persons with access to the Internet drug application (NDA).
Clonazepam may obtain the draft guidances at either The 1984 amendments include what
Edoxaban tosylate https://www.fda.gov/Drugs/Guidance is now section 505(j)(7) of the Federal
Gentamicin sulfate ComplianceRegulatoryInformation/ Food, Drug, and Cosmetic Act (21 U.S.C.

VerDate Sep<11>2014 15:18 May 16, 2017 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\17MYN1.SGM 17MYN1

22670 Federal Register / Vol. 82, No. 94 / Wednesday, May 17, 2017 / Notices

355(j)(7)), which requires FDA to was withdrawn from sale for reasons of petitions for such a determination under
publish a list of all approved drugs. safety or effectiveness (21 CFR 314.162). 21 CFR 10.25(a) and 10.30. Section
FDA publishes this list as part of the Under § 314.161(a) (21 CFR 314.161(d) provides that if FDA
‘‘Approved Drug Products With 314.161(a)), the Agency must determine determines that a listed drug was
Therapeutic Equivalence Evaluations,’’ whether a listed drug was withdrawn withdrawn from sale for safety or
which is generally known as the from sale for reasons of safety or effectiveness reasons, the Agency will
‘‘Orange Book.’’ Under FDA regulations, effectiveness: (1) Before an ANDA that initiate proceedings that could result in
a drug is removed from the list if the refers to that listed drug may be the withdrawal of approval of the
Agency withdraws or suspends approved, (2) whenever a listed drug is ANDAs that refer to the listed drug.
approval of the drug’s NDA or ANDA voluntarily withdrawn from sale and FDA has become aware that the drug
for reasons of safety or effectiveness, or ANDAs that refer to the listed drug have product listed in the table in this
if FDA determines that the listed drug been approved, and (3) when a person document is no longer being marketed.

Application Active
Drug name Strength(s) Dosage form/route Applicant
No. ingredient

NDA 018874 CALCIJEX .... Calcitriol ....... 1 microgram (mcg)/milliliter (mL); 2 mcg/mL ............... Injectable; Injection ...... AbbVie, Inc.

FDA has reviewed its records and, DEPARTMENT OF HEALTH AND term project topics—an environmental
under § 314.161, has determined that HUMAN SERVICES scan of terminology & vocabulary
the drug product listed in this document development, maintenance and
was not withdrawn from sale for reasons National Committee on Vital and Health dissemination processes on the first day;
of safety or effectiveness.1 Accordingly, Statistics: Meeting on the second day, building on past
the Agency will continue to list the drug Pursuant to the Federal Advisory work, exploration of a range of
product listed in this document in the Committee Act, the Department of challenges beyond HIPAA and the range
‘‘Discontinued Drug Product List’’ Health and Human Services (HHS) of policy options that may be available
section of the Orange Book. The announces the following advisory to the Department related to privacy,
‘‘Discontinued Drug Product List’’ committee meeting. security and access measures to protect
identifies, among other items, drug Name: National Committee on Vital individually identifiable health
products that have been discontinued and Health Statistics (NCVHS), Full information in an environment of
from marketing for reasons other than Committee Meeting. electronic networking and multiple uses
safety or effectiveness. Dates and Times: Wednesday, June of data. In addition, the Committee will
Approved ANDAs that refer to the 21, 2017: 9:00 a.m.–5:30 p.m. continue to focus on planning efforts
NDA listed in this document are Thursday, June 22, 2017: 8:30 a.m.– and follow-up items on actions from the
unaffected by the discontinued 3:15 p.m. previous day.
Place: U.S. Department of Health and The times and topics are subject to
marketing of the products subject to that
Human Services, Hubert H. Humphrey change. Please refer to the posted
NDA. Additional ANDAs that refer to
Building, 200 Independence Avenue agenda for any updates.
this product may also be approved by SW., Room 705A, Washington, DC
the Agency if they comply with relevant 20201, (202) 690–7100. Contact Person for More Information:
legal and regulatory requirements. If Status: Open. Substantive program information may
FDA determines that labeling for this Purpose: At the June 21–22, 2017 be obtained from Rebecca Hines, MHS,
drug product should be revised to meet meeting, the Committee will hear Executive Secretary, NCVHS, National
current standards, the Agency will presentations, hold discussions on Center for Health Statistics, Centers for
advise ANDA applicants to submit such several health data policy topics, and Disease Control and Prevention, 3311
labeling. receive updates from HHS, the Office of Toledo Road, Hyattsville, Maryland
This is not a significant regulatory the National Coordinator for Health IT, 20782, telephone (301) 458–4715.
action subject to Executive Order 12866 the CDC National Center for Health Summaries of meetings and a roster of
and does not impose any additional Statistics, the National Library of Committee members are available on the
burden on regulated entities. Medicine, and Centers for Medicare and home page of the NCVHS Web site:
Medicaid Services. On the first day, the http://www.ncvhs.hhs.gov/, where
Dated: May 11, 2017. Committee will focus on two items further information including an agenda
Anna K. Abram, anticipated for action: A and instructions to access the audio
Deputy Commissioner for Policy, Planning, recommendation letter that addresses broadcast of the meetings will also be
Legislation, and Analysis. the Health Plan Identifier in follow up posted. Should you require reasonable
[FR Doc. 2017–09960 Filed 5–16–17; 8:45 am] to the May 3, 2017 HPID Hearing, and accommodation, please contact the CDC
BILLING CODE 4164–01–P follow up on the NCVHS June 2016 Office of Equal Employment
Hearing on claims-based databases for Opportunity on (770) 488–3210 as soon
policy development and evaluation. The as possible.
Committee will review status reports on
nlaroche on DSK30NT082PROD with NOTICES

Dated: May 9, 2017.
various NCVHS products; an upcoming
hearing on the next generation of vital Laina Bush,
statistics; and the Predictability Deputy Assistant Secretary for Planning and
1 We have also determined that the previous
Roadmap under development by the Evaluation, Office of the Assistant Secretary
CALCIJEX formulation originally approved on
Standards Subcommittee. Significant for Planning and Evaluation.
September 25, 1986, and superseded by the
currently approved formulation was not withdrawn time will be devoted to discussion and [FR Doc. 2017–09982 Filed 5–16–17; 8:45 am]
for reasons of safety or effectiveness. formulation of two new complex long- BILLING CODE 4151–05–P

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Document Created: 2017-05-17 01:42:22
Document Modified: 2017-05-17 01:42:22

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		Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.
FR Citation		82 FR 22669

82 FR 22669 - Determination That CALCIJEX (Calcitriol) Injectable, 1 Microgram/Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 94 (May 17, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration