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PROLIXIN (Fluphenazine Hydrochloride) Tablets, 1 Milligram, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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)
Food and Drug Administration
Federal Register Volume 83, Issue 154 (August 9, 2018)
| Page Range | 39453-39454 | |
| FR Document | 2018-17026 |
[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] ----------------------------------------------------------------------- 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PROLIXIN (Fluphenazine Hydrochloride) Tablets, 1 Milligram, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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has determined that PROLIXIN (fluphenazine hydrochloride) tablets, 1 milligram (mg), 2.5 mg, 5 mg, and 10 mg, was not withdrawn from sale for reasons of safety or effectiveness.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, Stacy.Kane@fda.hhs.gov. 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
![Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 39453
on the label (2,160 ¥ 1,140 = 1,020 DEPARTMENT OF HEALTH AND for reasons of safety or effectiveness or
products not organics; 540 ¥ 285 = 255 HUMAN SERVICES if FDA determines that the listed drug
manufacturers of not organic products). was withdrawn from sale for reasons of
In addition, the 54 livestock feed Food and Drug Administration safety or effectiveness (21 CFR 314.162).
suppliers are also organic producers, [Docket No. FDA–2018–P–0998]
A person may petition the Agency to
thus the 216 products attributed to these determine, or the Agency may
manufacturers already are considered to Determination That PROLIXIN determine on its own initiative, whether
be labeled ‘‘organic.’’ Thus, there are (Fluphenazine Hydrochloride) Tablets, a listed drug was withdrawn from sale
1,020 products made by 255 human 1 Milligram, 2.5 Milligrams, 5 for reasons of safety or effectiveness.
food and pet food manufacturers that Milligrams, and 10 Milligrams, Was Not This determination may be made at any
would need to substantiate that their Withdrawn From Sale for Reasons of time after the drug has been withdrawn
product or ingredient was not Safety or Effectiveness from sale, but must be made prior to
genetically engineered. approving an ANDA that refers to the
AGENCY: Food and Drug Administration, listed drug (§ 314.161 (21 CFR 314.161)).
We estimate that the burden of HHS. FDA may not approve an ANDA that
maintaining the documentation is a one- ACTION: Notice. does not refer to a listed drug.
time burden; the document to PROLIXIN (fluphenazine
substantiate that the product or SUMMARY: The Food and Drug hydrochloride) tablets, 1 mg, 2.5 mg, 5
ingredient was produced without Administration (FDA or Agency) has mg, and 10 mg, is the subject of NDA
genetic engineering only needs to be determined that PROLIXIN 011751, held by Apothecon
generated once and then kept on file. To (fluphenazine hydrochloride) tablets, 1 Pharmaceuticals, a Bristol-Myers Squibb
annualize this one-time burden, we milligram (mg), 2.5 mg, 5 mg, and 10 Company, and initially approved on
divide by 3 because paperwork burden mg, was not withdrawn from sale for March 15, 1967. PROLIXIN is indicated
collections are approved on a 3-year reasons of safety or effectiveness. This in the management of manifestations of
cycle (255/3 = 85). Thus, we estimate in determination will allow FDA to psychotic disorders.
approve abbreviated new drug In a letter dated October 5, 2006,
table 1 that, on average, 85
applications (ANDAs) for fluphenazine Bristol-Myers Squibb Company
manufacturers annually will collect and
hydrochloride tablets, 1 mg, 2.5 mg, 5 requested withdrawal of NDA 011751
keep information that substantiates their
mg, and 10 mg, if all other legal and for PROLIXIN (fluphenazine
label claim for four products (1,020 regulatory requirements are met.
products/3 = 340 products/85 hydrochloride) tablets, 1 mg, 2.5 mg, 5
FOR FURTHER INFORMATION CONTACT: mg, and 10 mg. In the Federal Register
manufacturers = 4 products per
Stacy Kane, Center for Drug Evaluation of February 11, 2009 (74 FR 6896), FDA
manufacturer).
and Research, Food and Drug announced that it was withdrawing
We estimate this one-time Administration, 10903 New Hampshire approval of NDA 011751, effective
recordkeeping burden to be 1 hour per Ave., Bldg. 51, Rm. 6236, Silver Spring, March 13, 2009.
product that makes use of a labeling MD 20993–0002, 301–796–8363, Hyman, Phelps & McNamara, P.C.
claim, which results in a burden of 1 Stacy.Kane@fda.hhs.gov. submitted a citizen petition dated
hour for a total annualized SUPPLEMENTARY INFORMATION: In 1984, March 5, 2018 (Docket No. FDA–2018–
recordkeeping burden of 340 hours (85 Congress enacted the Drug Price P–0998), under 21 CFR 10.30,
manufacturers × 4 records per Competition and Patent Term requesting that the Agency determine
manufacturer × 1 hour per record). Restoration Act of 1984 (Pub. L. 98–417) whether PROLIXIN (fluphenazine
We do not estimate any reporting (the 1984 amendments), which hydrochloride) tablets, 1 mg, 2.5 mg, 5
burden or third-party disclosure burden authorized the approval of duplicate mg, and 10 mg, was withdrawn from
associated with this information versions of drug products under an sale for reasons of safety or
collection. Manufacturers who want to ANDA procedure. ANDA applicants effectiveness.
make use of this voluntary labeling must, with certain exceptions, show that After considering the citizen petition
claim option are considered to be those the drug for which they are seeking and reviewing Agency records and
approval contains the same active based on the information we have at this
that already have such wording on their
ingredient in the same strength and time, FDA has determined under
products’ labels. We do not expect that
dosage form as the ‘‘listed drug,’’ which § 314.161 that PROLIXIN (fluphenazine
this guidance will cause labels already
is a version of the drug that was hydrochloride) tablets, 1 mg, 2.5 mg, 5
in the marketplace to need to be previously approved. ANDA applicants mg, and 10 mg, was not withdrawn for
reworded. do not have to repeat the extensive reasons of safety or effectiveness. The
Dated: August 3, 2018. clinical testing otherwise necessary to petitioner has identified no data or other
Leslie Kux, gain approval of an NDA. information suggesting that PROLIXIN
Associate Commissioner for Policy. The 1984 amendments include what (fluphenazine hydrochloride) tablets, 1
[FR Doc. 2018–17024 Filed 8–8–18; 8:45 am]
is now section 505(j)(7) of the Federal mg, 2.5 mg, 5 mg, and 10 mg, was
Food, Drug, and Cosmetic Act (21 U.S.C. withdrawn for reasons of safety or
BILLING CODE 4164–01–P
355(j)(7)), which requires FDA to effectiveness. We have carefully
publish a list of all approved drugs. reviewed our files for records
FDA publishes this list as part of the concerning the withdrawal of PROLIXIN
sradovich on DSK3GMQ082PROD with NOTICES
‘‘Approved Drug Products With (fluphenazine hydrochloride) tablets, 1
Therapeutic Equivalence Evaluations,’’ mg, 2.5 mg, 5 mg, and 10 mg, from sale.
which is known generally as the We have also independently evaluated
‘‘Orange Book.’’ Under FDA regulations, relevant literature and data for possible
drugs are removed from the list if the postmarketing adverse events. We have
Agency withdraws or suspends found no information that would
approval of the drug’s NDA or ANDA indicate that this drug product was
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![39454 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
withdrawn from sale for reasons of SUPPLEMENTARY INFORMATION: Dated: July 25, 2018.
safety or effectiveness. Technology description follows. Suzanne M. Frisbie,
Accordingly, the Agency will Deputy Director, Technology Transfer and
continue to list PROLIXIN Stabilized Group 2 Influenza
Intellectual Property Office, National Institute
(fluphenazine hydrochloride) tablets, 1 Hemagglutinin Stem Region Trimers of Allergy and Infectious Diseases.
mg, 2.5 mg, 5 mg, and 10 mg, in the and Uses Thereof
[FR Doc. 2018–17036 Filed 8–8–18; 8:45 am]
‘‘Discontinued Drug Product List’’ Description of Technology: BILLING CODE 4140–01–P
section of the Orange Book. The Researchers at the Vaccine Research
‘‘Discontinued Drug Product List’’ Center of the National Institute of
delineates, among other items, drug Allergy and Infectious Diseases (NIAID) DEPARTMENT OF HOMELAND
products that have been discontinued have designed influenza vaccine SECURITY
from marketing for reasons other than candidates based on group 2 influenza
safety or effectiveness. ANDAs that refer hemagglutinin (HA) proteins. These U.S. Customs and Border Protection
to PROLIXIN (fluphenazine group 2 HA proteins were engineered to [1651–0138]
hydrochloride) tablets, 1 mg, 2.5 mg, 5 remove the highly variable head region
mg, and 10 mg, may be approved by the and stabilize the remaining stem region. Agency Information Collection
Agency as long as they meet all other The researchers then fused the Activities: Biometric Identity
legal and regulatory requirements for engineered group 2 HA stabilized stem
the approval of ANDAs. If FDA with a ferritin subunit. The resulting AGENCY: U.S. Customs and Border
determines that labeling for this drug fusion protein can self-assemble into Protection (CBP), Department of
product should be revised to meet nanoparticles which display group 2 HA Homeland Security.
current standards, the Agency will stem domain trimers on their surface. ACTION: 30-Day notice and request for
advise ANDA applicants to submit such These immunogens elicit cross- comments; revision and extension of an
labeling. reactive antibodies to group 2 influenza existing collection of information.
Dated: August 3, 2018. viruses and could be used in SUMMARY: The Department of Homeland
Leslie Kux, combination with group 1 HA stem- Security, U.S. Customs and Border
Associate Commissioner for Policy. ferritin immunogens as a universal Protection will be submitting the
[FR Doc. 2018–17026 Filed 8–8–18; 8:45 am] influenza vaccine. Interestingly, a recent following information collection request
BILLING CODE 4164–01–P
study by Andrews et al., Sci. Immunol. to the Office of Management and Budget
2, eaan2676 (2017), suggests that cross- (OMB) for review and approval in
reactive group 1/group 2 HA stem accordance with the Paperwork
DEPARTMENT OF HEALTH AND antibodies may be more likely to be Reduction Act of 1995 (PRA). The
HUMAN SERVICES elicited in humans by a group 2 HA information collection is published in
immunogen. the Federal Register to obtain comments
National Institutes of Health This technology is available for from the public and affected agencies.
licensing for commercial development DATES: Comments are encouraged and
Government-Owned Inventions; in accordance with 35 U.S.C. 209 and 37
Availability for Licensing will be accepted (no later than
CFR part 404. September 10, 2018]) to be assured of
AGENCY: National Institutes of Health, Potential Commercial Applications: consideration.
HHS. • Use as a broadly protective influenza ADDRESSES: Interested persons are
ACTION: Notice. vaccine invited to submit written comments on
SUMMARY: The invention listed below is Competitive Advantages: this proposed information collection to
owned by an agency of the U.S. • Elicits antibodies to both group 1 and the Office of Information and Regulatory
Government and is available for group 2 influenza A viruses Affairs, Office of Management and
licensing to achieve expeditious • Nucleic acid or recombinant protein- Budget. Comments should be addressed
commercialization of results of based vaccine to the OMB Desk Officer for Customs
federally-funded research and • Increased ease of production and Border Protection, Department of
development. Foreign patent compared to current seasonal Homeland Security, and sent via
applications are filed on selected influenza vaccines electronic mail to dhsdeskofficer@
inventions to extend market coverage omb.eop.gov.
Development Stage:
for companies and may also be available FOR FURTHER INFORMATION CONTACT:
for licensing. • In vivo (animal studies)
Requests for additional PRA information
FOR FURTHER INFORMATION CONTACT: Inventors: Jeffrey C. Boyington, should be directed to Seth Renkema,
Amy F. Petrik, Ph.D., 240–627–3721, Barney S. Graham, John R. Mascola, Chief, Economic Impact Analysis
amy.petrik@nih.gov. Licensing Hadi M. Yassine, Syed M. Moin, Branch, U.S. Customs and Border
information and copies of the U.S. Lingshu Wang, Kizzmekia S. Corbett, Protection, Office of Trade, Regulations
patent application listed below may be Masaru Kanekiyo (all from NIAID). and Rulings, 90 K Street NE, 10th Floor,
obtained by communicating with the Intellectual Property: HHS Reference Washington, DC 20229–1177,
indicated licensing contact at the Number E–228–2016 includes U.S. Telephone number (202) 325–0056 or
Technology Transfer and Intellectual Provisional 62/383,267 filed 2 via email CBP_PRA@cbp.dhs.gov. Please
sradovich on DSK3GMQ082PROD with NOTICES
Property Office, National Institute of September 2016 and PCT Patent note that the contact information
Allergy and Infectious Diseases, 5601 Application No. PCT/US2017/049894 provided here is solely for questions
Fishers Lane, Rockville, MD 20852; tel. filed 1 September 2017 (pending). regarding this notice. Individuals
301–496–2644. A signed Confidential Related Intellectual Property: HHS seeking information about other CBP
Disclosure Agreement will be required Reference Number E–293–2011. programs should contact the CBP
to receive copies of unpublished patent Licensing Contact: Dr. Amy Petrik, National Customer Service Center at
applications. 240–627–3721; amy.petrik@nih.gov. 877–227–5511, (TTY) 1–800–877–8339,
VerDate Sep<11>2014 18:11 Aug 08, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1](https://thefederalregister.org/doc/83_FR_39607/page/2.svg)
Document Created: 2018-08-09 01:10:48
Document Modified: 2018-08-09 01:10:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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] | |
| FR Citation | 83 FR 39453 |
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