[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Pages 39453-39454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17026]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-0998]
Determination That PROLIXIN (Fluphenazine Hydrochloride) Tablets,
1 Milligram, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 PROLIXIN (fluphenazine hydrochloride) tablets, 1
milligram (mg), 2.5 mg, 5 mg, and 10 mg, was not withdrawn from sale
for reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for
fluphenazine hydrochloride tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, if
all other legal and regulatory requirements are met.
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,
[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 an 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.
PROLIXIN (fluphenazine hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg,
and 10 mg, is the subject of NDA 011751, held by Apothecon
Pharmaceuticals, a Bristol-Myers Squibb Company, and initially approved
on March 15, 1967. PROLIXIN is indicated in the management of
manifestations of psychotic disorders.
In a letter dated October 5, 2006, Bristol-Myers Squibb Company
requested withdrawal of NDA 011751 for PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg. In the Federal
Register of February 11, 2009 (74 FR 6896), FDA announced that it was
withdrawing approval of NDA 011751, effective March 13, 2009.
Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated
March 5, 2018 (Docket No. FDA-2018-P-0998), under 21 CFR 10.30,
requesting that the Agency determine whether PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, 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 PROLIXIN (fluphenazine hydrochloride) tablets,
1 mg, 2.5 mg, 5 mg, and 10 mg, was not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that PROLIXIN (fluphenazine hydrochloride)
tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 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
[[Page 39454]]
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list PROLIXIN
(fluphenazine hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 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 PROLIXIN
(fluphenazine hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 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: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17026 Filed 8-8-18; 8:45 am]
BILLING CODE 4164-01-P