82 FR 51282 - Determination That REVEX (Nalmefene Hydrochloride Injection), 0.1 Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 212 (November 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 212 (November 3, 2017)
| Page Range | 51282-51283 | |
| FR Document | 2017-23952 |
[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)] [Notices] [Pages 51282-51283] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23952] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-P-2044] Determination That REVEX (Nalmefene Hydrochloride Injection), 0.1 Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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that REVEX (nalmefene hydrochloride injection), 0.1 milligram (mg) base/milliliter (mL) and 1.0 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness.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 REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Kelley Nduom, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993-0002, 301- 796-8597. 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, a drug is 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. REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, is the subject of NDA 20-459, currently held by West-Ward Pharmaceuticals International Limited, and initially approved on April 17, 1995. REVEX is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. REVEX is also indicated in the management of known or suspected opioid overdose. In a letter dated June 5, 2009, Baxter Healthcare Corporation, the NDA holder at the time, notified FDA that the manufacturing and distribution of REVEX (nalmefene hydrochloride injection), 0.1 mg base/ mL and 1.0 mg base/mL, had been discontinued on May 21, 2008, for business reasons. REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, is currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. Nirsum Pharmaceuticals, LLC, submitted a citizen petition dated March 31, 2017 (Docket No. FDA-2017- [[Page 51283]] P-2044), under 21 CFR 10.30, requesting that the Agency determine whether REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition (and comments submitted to the docket) and reviewing Agency records, and based on the information we have at this time, FDA has determined under Sec. 314.161 that REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, 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 REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/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. ANDAs that refer to this drug product 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 19, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23952 Filed 11-2-17; 8:45 am] BILLING CODE 4164-01-P
![51282 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
21 CFR section responses per annual burden per Total hours
respondents respondent responses response
589.2001(f); request for designation .................................... 1 1 1 80 80
589.2001(f); response to request for review by FDA .......... 1 1 1 26 26
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate of the reporting burden DEPARTMENT OF HEALTH AND The 1984 amendments include what
for designation under § 589.2001(f) is HUMAN SERVICES is now section 505(j)(7) of the Federal
based on estimates in the final rule Food, Drug, and Cosmetic Act (21 U.S.C.
entitled, ‘‘Substances Prohibited From Food and Drug Administration 355(j)(7)), which requires FDA to
Use in Animal Food or Feed,’’ publish a list of all approved drugs.
published in the Federal Register of [Docket No. FDA–2017–P–2044] FDA publishes this list as part of the
April 25, 2008, our experience, and the ‘‘Approved Drug Products With
Determination That REVEX (Nalmefene Therapeutic Equivalence Evaluations,’’
average number of requests for
Hydrochloride Injection), 0.1 Milligram which is known generally as the
designation received in the past 3 years.
Base/Milliliter and 1.0 Milligram Base/ ‘‘Orange Book.’’ Under FDA regulations,
The reporting burden for § 589.2001(f) is
Milliliter, Was Not Withdrawn From a drug is removed from the list if the
minimal because requests for Sale for Reasons of Safety or
designation are seldom submitted. Since Agency withdraws or suspends
Effectiveness approval of the drug’s NDA or ANDA
2009, we have received two requests for
AGENCY: Food and Drug Administration, for reasons of safety or effectiveness or
designation. In the last 3 years, we have
HHS. if FDA determines that the listed drug
not received any new requests for was withdrawn from sale for reasons of
designation; therefore, we estimate that ACTION: Notice. safety or effectiveness (21 CFR 314.162).
one or fewer requests for designation A person may petition the Agency to
will be submitted annually. Although SUMMARY: The Food and Drug
Administration (FDA or Agency) has determine, or the Agency may
we have not received any new requests determine on its own initiative, whether
for designation in the last 3 years, we determined that REVEX (nalmefene
hydrochloride injection), 0.1 milligram a listed drug was withdrawn from sale
believe these information collection for reasons of safety or effectiveness.
(mg) base/milliliter (mL) and 1.0 mg
provisions should be extended to This determination may be made at any
base/mL, was not withdrawn from sale
provide for the potential future need of time after the drug has been withdrawn
for reasons of safety or effectiveness.
a foreign government to request This determination will allow FDA to from sale, but must be made prior to
designation under § 589.2001(f). Table approve abbreviated new drug approving an ANDA that refers to the
2, row 1 presents the expected burden applications (ANDAs) for REVEX listed drug (§ 314.161 (21 CFR 314.161)).
of requests for designation. Countries (nalmefene hydrochloride injection), 0.1 FDA may not approve an ANDA that
designated under § 589.2001(f) are mg base/mL and 1.0 mg base/mL, if all does not refer to a listed drug.
subject to review by FDA to ensure that REVEX (nalmefene hydrochloride
other legal and regulatory requirements
their designation remains appropriate. injection), 0.1 mg base/mL and 1.0 mg
are met.
We assume a country’s response to a base/mL, is the subject of NDA 20–459,
FOR FURTHER INFORMATION CONTACT: currently held by West-Ward
request for review will take about one Kelley Nduom, Center for Drug
third the time and effort of a request for Pharmaceuticals International Limited,
Evaluation and Research, Food and and initially approved on April 17,
designation. Table 2, row 2 presents the Drug Administration, 10903 New 1995. REVEX is indicated for the
expected burden of a request for review. Hampshire Ave., Bldg. 51, Rm. 6221, complete or partial reversal of opioid
The burden for this information Silver Spring, MD 20993–0002, 301– drug effects, including respiratory
collection has not changed since the last 796–8597. depression, induced by either natural or
OMB approval. SUPPLEMENTARY INFORMATION: In 1984, synthetic opioids. REVEX is also
Dated: October 24, 2017. Congress enacted the Drug Price indicated in the management of known
Anna K. Abram, Competition and Patent Term or suspected opioid overdose.
Restoration Act of 1984 (Pub. L. 98–417) In a letter dated June 5, 2009, Baxter
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
(the 1984 amendments), which Healthcare Corporation, the NDA holder
authorized the approval of duplicate at the time, notified FDA that the
[FR Doc. 2017–23948 Filed 11–2–17; 8:45 am]
versions of drug products under an manufacturing and distribution of
BILLING CODE 4164–01–P
ANDA procedure. ANDA applicants REVEX (nalmefene hydrochloride
must, with certain exceptions, show that injection), 0.1 mg base/mL and 1.0 mg
the drug for which they are seeking base/mL, had been discontinued on May
approval contains the same active 21, 2008, for business reasons. REVEX
ingredient in the same strength and (nalmefene hydrochloride injection), 0.1
ethrower on DSK3G9T082PROD with NOTICES
dosage form as the ‘‘listed drug,’’ which mg base/mL and 1.0 mg base/mL, is
is a version of the drug that was currently listed in the ‘‘Discontinued
previously approved. ANDA applicants Drug Product List’’ section of the Orange
do not have to repeat the extensive Book.
clinical testing otherwise necessary to Nirsum Pharmaceuticals, LLC,
gain approval of a new drug application submitted a citizen petition dated
(NDA). March 31, 2017 (Docket No. FDA–2017–
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![Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 51283
P–2044), under 21 CFR 10.30, DEPARTMENT OF HOMELAND 44 U.S.C. 35, as amended. An ICR is an
requesting that the Agency determine SECURITY application to OIRA seeking the
whether REVEX (nalmefene approval, extension, or renewal of a
hydrochloride injection), 0.1 mg base/ Coast Guard Coast Guard collection of information
mL and 1.0 mg base/mL, was withdrawn [Docket No. USCG–2017–0109; Control (Collection). The ICR contains
from sale for reasons of safety or Number: 1625–0030] information describing the Collection’s
effectiveness. purpose, the Collection’s likely burden
Collection of Information Under on the affected public, an explanation of
After considering the citizen petition the necessity of the Collection, and
Review by Office of Management and
(and comments submitted to the docket) Budget; OMB other important information describing
and reviewing Agency records, and the Collection. There is one ICR for each
based on the information we have at this AGENCY:Coast Guard, DHS. Collection. The Coast Guard invites
time, FDA has determined under Thirty-day notice requesting
ACTION: comments on whether this ICR should
§ 314.161 that REVEX (nalmefene comments. be granted based on the Collection being
hydrochloride injection), 0.1 mg base/ necessary for the proper performance of
mL and 1.0 mg base/mL, was not SUMMARY: In compliance with the Departmental functions. In particular,
withdrawn for reasons of safety or Paperwork Reduction Act of 1995 the the Coast Guard would appreciate
effectiveness. The petitioner has U.S. Coast Guard is forwarding an comments addressing: (1) The practical
identified no data or other information Information Collection Request (ICR), utility of the Collection; (2) the accuracy
abstracted below, to the Office of of the estimated burden of the
suggesting that REVEX (nalmefene
Management and Budget (OMB), Office Collection; (3) ways to enhance the
hydrochloride injection), 0.1 mg base/
of Information and Regulatory Affairs quality, utility, and clarity of
mL and 1.0 mg base/mL, was withdrawn
(OIRA), requesting approval for information subject to the Collection;
for reasons of safety or effectiveness. We reinstatement, without change, of the
have carefully reviewed our files for and (4) ways to minimize the burden of
following collection of information: the Collection on respondents,
records concerning the withdrawal of 1625–0030, Oil and Hazardous including the use of automated
REVEX (nalmefene hydrochloride Materials Transfer Procedures. Our ICR collection techniques or other forms of
injection), 0.1 mg base/mL and 1.0 mg describes the information we seek to information technology. These
base/mL, from sale. We have also collect from the public. Review and comments will help OIRA determine
independently evaluated relevant comments by OIRA ensure we only whether to approve the ICR referred to
literature and data for possible impose paperwork burdens in this Notice.
postmarketing adverse events. We have commensurate with our performance of We encourage you to respond to this
found no information that would duties. request by submitting comments and
indicate that this drug product was DATES: Comments must reach the Coast related materials. Comments to Coast
withdrawn from sale for reasons of Guard and OIRA on or before December Guard or OIRA must contain the OMB
safety or effectiveness. 4, 2017. Control Number of the ICR. They must
Accordingly, the Agency will ADDRESSES: You may submit comments also contain the docket number of this
continue to list REVEX (nalmefene identified by Coast Guard docket request [USCG–2017–0109], and must
number [USCG–2017–0109] to the Coast be received by December 4, 2017.
hydrochloride injection), 0.1 mg base/
mL and 1.0 mg base/mL, in the Guard using the Federal eRulemaking Submitting Comments
‘‘Discontinued Drug Product List’’ Portal at http://www.regulations.gov. We encourage you to submit
section of the Orange Book. The Alternatively, you may submit comments through the Federal
‘‘Discontinued Drug Product List’’ comments to OIRA using one of the eRulemaking Portal at http://
delineates, among other items, drug following means: www.regulations.gov. If your material
products that have been discontinued (1) Email: dhsdeskofficer@ cannot be submitted using http://
from marketing for reasons other than omb.eop.gov. www.regulations.gov, contact the person
safety or effectiveness. ANDAs that refer (2) Mail: OIRA, 725 17th Street NW., in the FOR FURTHER INFORMATION
Washington, DC 20503, attention Desk CONTACT section of this document for
to this drug product may be approved
Officer for the Coast Guard. alternate instructions. Documents
by the Agency as long as they meet all
A copy of the ICR is available through mentioned in this notice, and all public
other legal and regulatory requirements the docket on the Internet at http://
for the approval of ANDAs. If FDA comments, are in our online docket at
www.regulations.gov. Additionally, http://www.regulations.gov and can be
determines that labeling for this drug copies are available from: Commandant
product should be revised to meet viewed by following that Web site’s
(CG–612), Attn: Paperwork Reduction instructions. Additionally, if you go to
current standards, the Agency will Act Manager, U.S. Coast Guard, 2703
advise ANDA applicants to submit such the online docket and sign up for email
Martin Luther King Jr. Ave. SE., Stop alerts, you will be notified when
labeling. 7710, Washington, DC 20593–7710. comments are posted.
Dated: October 19, 2017. FOR FURTHER INFORMATION CONTACT: Mr. We accept anonymous comments. All
Anna K. Abram, Anthony Smith, Office of Information comments received will be posted
Deputy Commissioner for Policy, Planning, Management, telephone 202–475–3532, without change to http://
Legislation, and Analysis. or fax 202–372–8405, for questions on www.regulations.gov and will include
ethrower on DSK3G9T082PROD with NOTICES
[FR Doc. 2017–23952 Filed 11–2–17; 8:45 am]
these documents. any personal information you have
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION: provided. For more about privacy and
the docket, you may review a Privacy
Public Participation and Request for Act notice regarding the Federal Docket
Comments Management System in the March 24,
This Notice relies on the authority of 2005, issue of the Federal Register (70
the Paperwork Reduction Act of 1995; FR 15086).
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Document Created: 2018-10-25 10:22:44
Document Modified: 2018-10-25 10:22:44
| 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 | Kelley Nduom, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993-0002, 301- 796-8597. | |
| FR Citation | 82 FR 51282 |
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