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REVEX (Nalmefene Hydrochloride Injection), 0.1 Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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)

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that REVEX (nalmefene hydrochloride injection), 0.1 milligram (mg) base/milliliter (mL) and 1.0 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness.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.

[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]


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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Withdrawn From Sale for Reasons of Safety or Effectiveness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.

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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withdrawn from sale for reasons of safety or effectiveness.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