[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49840-49841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23438]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-2660]


Determination That CARDENE SR (Nicardipine HCl) Extended-Release 
Capsules, 30 Milligrams, 45 Milligrams, and 60 Milligrams, Were 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 CARDENE SR (nicardipine HCl) extended-release capsules, 
30 milligrams (mg), 45 mg, and 60 mg, were not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for nicardipine 
HCl extended-release capsules, 30 mg, 45 mg, and 60 mg, if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301-
796-6650.

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

[[Page 49841]]

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.
    CARDENE SR (nicardipine HCl) extended-release capsules, 30 mg, 45 
mg, and 60 mg, are the subject of NDA 020005, initially approved on 
February 21, 1992. CARDENE SR is indicated for the treatment of 
hypertension.
    In a letter dated September 15, 2014, EKR Therapeutics, Inc., 
requested withdrawal of NDA 020005 for CARDENE SR (nicardipine HCl) 
extended-release capsules, 30 mg, 45 mg, and 60 mg. In the Federal 
Register of October 4, 2016 (81 FR 68427), FDA announced that it was 
withdrawing approval of NDA 020005, effective November 3, 2016.
    Jubilant Generics submitted a citizen petition dated April 27, 2017 
(Docket No. FDA-2017-P-2660), under 21 CFR 10.30, requesting that the 
Agency determine whether CARDENE SR (nicardipine HCl) extended-release 
capsules, 30 mg, 45 mg, and 60 mg, were withdrawn from sale for reasons 
of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that CARDENE SR (nicardipine HCl) extended-release 
capsules, 30 mg, 45 mg, and 60 mg, were not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that CARDENE SR (nicardipine HCl) extended-
release capsules, 30 mg, 45 mg, and 60 mg, were withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of CARDENE SR (nicardipine HCl) 
extended-release capsules, 30 mg, 45 mg, and 60 mg from sale. We have 
also independently evaluated relevant literature and data for possible 
postmarketing adverse events. We have found no information that would 
indicate that this drug product was withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list CARDENE SR 
(nicardipine HCl) extended-release capsules, 30 mg, 45 mg, and 60 mg, 
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 CARDENE SR 
(nicardipine HCl) extended-release capsules, 30 mg, 45 mg, or 60 mg, 
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 this drug product should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.

    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23438 Filed 10-26-17; 8:45 am]
 BILLING CODE 4164-01-P


