83 FR 39453 - 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PROLIXIN (Fluphenazine Hydrochloride) Tablets, 1 Milligram, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 154 (August 9, 2018)

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has determined that PROLIXIN (fluphenazine hydrochloride) tablets, 1 milligram (mg), 2.5 mg, 5 mg, and 10 mg, was not withdrawn from sale for reasons of safety or effectiveness.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.

[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Pages 39453-39454]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17026]


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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Withdrawn From Sale for Reasons of Safety or Effectiveness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.

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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milligram (mg), 2.5 mg, 5 mg, and 10 mg, was not withdrawn from sale 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