[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3933-3934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01062]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-1525]
Determination That CARDENE (Nicardipine Hydrochloride) Injection,
25 Milligrams/10 Milliliters, Was Not Withdrawn From Sale for Reasons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 CARDENE (nicardipine hydrochloride) injection, 25
milligrams (mg)/10 milliliters (mL), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for nicardipine
hydrochloride injection, 25 mg/10 mL, 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. 6210, Silver Spring, MD 20993-0002, 301-
796-6650, [email protected].
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drug was withdrawn from sale for reasons of safety or effectiveness (21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.
CARDENE (nicardipine hydrochloride) injection, 25 mg/10 mL, is the
subject of NDA 019734, held by Chiesi USA, Inc., and initially approved
on January 30, 1992. CARDENE is indicated for short-term treatment of
hypertension when oral therapy is not feasible or not desirable.
In a letter dated February 13, 2018, Chiesi USA, Inc. notified FDA
that CARDENE (nicardipine hydrochloride) injection, 25 mg/10 mL, was
being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Baxter Healthcare Corporation submitted a citizen petition on May
6, 2019 (Docket No. FDA-2019-P-1525), under 21 CFR 10.30, requesting
that the Agency determine whether CARDENE (nicardipine hydrochloride)
injection, 25 mg/10 mL, was 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 (nicardipine hydrochloride) injection,
25 mg/10 mL, was not withdrawn for reasons of safety or effectiveness.
The petitioner has identified no data or other information suggesting
that this drug product was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of CARDENE (nicardipine hydrochloride)
injection, 25 mg/10 mL, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events.
We have found no information that would
[[Page 3934]]
indicate that this drug product was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list CARDENE (nicardipine
hydrochloride) injection, 25 mg/10 mL, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also 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: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01062 Filed 1-22-20; 8:45 am]
BILLING CODE 4164-01-P