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- Determination That CALCIJEX (Calcitriol) Injectable, 1 Microgram/Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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

The Food and Drug Administration (FDA or Agency) has determined that the drug product listed in this document was not withdrawn from sale for reasons of safety or effectiveness.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, 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Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for 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.

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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withdrawn from sale for reasons of safety or effectiveness.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.

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