Determination That CALCIJEX (Calcitriol) Injectable, 1 Microgram/Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 22669-22670 [2017-09960]

Download as PDF Federal Register / Vol. 82, No. 94 / Wednesday, May 17, 2017 / Notices TABLE 1—NEW DRAFT PRODUCT-SPE- Guidances/default.htm or https:// CIFIC GUIDANCES FOR DRUG PROD- www.regulations.gov. UCTS—Continued Dated: May 11, 2017. Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993–0002, 301– 796–5850. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific guidances available to the public on FDA’s Web site at https:// www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA’s Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the Federal Register on December 23, 2016 (81 FR 94394). This notice announces draft productspecific guidances, either new or revised, that are posted on FDA’s Web site. Hydrocortisone Hydrocortisone butyrate Linagliptin; Metformin hydrochloride Lorcaserin hydrochloride Methylnaltrexone bromide Nitroglycerin Nystatin; Triamcinolone acetonide (multiple reference listed drugs) Oxymetazoline hydrochloride; Tetracaine hydrochloride Sofosbuvir; Velpatasvir Venetoclax FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients: nlaroche on DSK30NT082PROD with NOTICES VerDate Sep<11>2014 15:18 May 16, 2017 Acamprosate calcium Apixaban Bexarotene Calcium acetate (multiple reference listed drugs) Deferiprone Dolutegravir sodium Emtricitabine; Tenofovir disoproxil fumarate Fingolimod Lanthanum carbonate Nevirapine Phenytoin (multiple reference listed drugs) Propafenone hydrochloride Trospium chloride (multiple reference listed drugs) IV. Electronic Access Jkt 241001 [FR Doc. 2017–09961 Filed 5–16–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 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. TABLE 2—REVISED DRAFT PRODUCT- SUMMARY: The Food and Drug SPECIFIC GUIDANCES FOR DRUG Administration (FDA or Agency) has PRODUCTS determined that the drug product listed For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA–2007–D–0369. These draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current thinking of FDA on, among other things, UCTS the product-specific design of BE studies to support ANDAs. They do not Acetylcysteine establish any rights for any person and Amphetamine are not binding on FDA or the public. Aprepitant You can use an alternative approach if Azelastine hydrochloride Bisacodyl; polyethylene glycol 3350; potasit satisfies the requirements of the sium chloride; sodium bicarbonate; sodium applicable statutes and regulations. Clidinium Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [Docket No. FDA–2017–N–2364] III. Drug Products for Which Revised Draft Product-Specific Guidances are Available II. Drug Products for Which New Draft Product-Specific Guidances are Available FDA is announcing the availability of a new draft product-specific guidances for industry for drug products containing the following active ingredients: chloride Carbidopa; levodopa Chlordiazepoxide hydrochloride; bromide Clonazepam Edoxaban tosylate Gentamicin sulfate 22669 Persons with access to the Internet may obtain the draft guidances at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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. 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 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 § 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 NDA 018874 CALCIJEX .... Calcitriol ....... 1 microgram (mcg)/milliliter (mL); 2 mcg/mL ............... Injectable; Injection ...... FDA has reviewed its records and, under § 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. 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] nlaroche on DSK30NT082PROD with NOTICES BILLING CODE 4164–01–P 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. VerDate Sep<11>2014 15:18 May 16, 2017 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. Name: National Committee on Vital and Health Statistics (NCVHS), Full Committee Meeting. Dates and Times: Wednesday, June 21, 2017: 9:00 a.m.–5:30 p.m. Thursday, June 22, 2017: 8:30 a.m.– 3:15 p.m. Place: U.S. Department of Health and Human Services, Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 705A, Washington, DC 20201, (202) 690–7100. Status: Open. Purpose: At the June 21–22, 2017 meeting, the Committee will hear presentations, hold discussions on several health data policy topics, and receive updates from HHS, the Office of the National Coordinator for Health IT, the CDC National Center for Health Statistics, the National Library of Medicine, and Centers for Medicare and Medicaid Services. On the first day, the Committee will focus on two items anticipated for action: A recommendation letter that addresses the Health Plan Identifier in follow up to the May 3, 2017 HPID Hearing, and follow up on the NCVHS June 2016 Hearing on claims-based databases for policy development and evaluation. The Committee will review status reports on various NCVHS products; an upcoming hearing on the next generation of vital statistics; and the Predictability Roadmap under development by the Standards Subcommittee. Significant time will be devoted to discussion and formulation of two new complex long- PO 00000 Frm 00028 Fmt 4703 Sfmt 9990 Applicant AbbVie, Inc. term project topics—an environmental scan of terminology & vocabulary development, maintenance and dissemination processes on the first day; on the second day, building on past work, exploration of a range of challenges beyond HIPAA and the range of policy options that may be available to the Department related to privacy, security and access measures to protect individually identifiable health information in an environment of electronic networking and multiple uses of data. In addition, the Committee will continue to focus on planning efforts and follow-up items on actions from the previous day. The times and topics are subject to change. Please refer to the posted agenda for any updates. Contact Person for More Information: Substantive program information may be obtained from Rebecca Hines, MHS, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, telephone (301) 458–4715. Summaries of meetings and a roster of Committee members are available on the home page of the NCVHS Web site: http://www.ncvhs.hhs.gov/, where further information including an agenda and instructions to access the audio broadcast of the meetings will also be posted. Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (770) 488–3210 as soon as possible. Dated: May 9, 2017. Laina Bush, Deputy Assistant Secretary for Planning and Evaluation, Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 2017–09982 Filed 5–16–17; 8:45 am] BILLING CODE 4151–05–P E:\FR\FM\17MYN1.SGM 17MYN1

Agencies

[Federal Register Volume 82, Number 94 (Wednesday, May 17, 2017)]
[Notices]
[Pages 22669-22670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09960]


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

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.
---------------------------------------------------------------------------

    \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