[Federal Register Volume 84, Number 66 (Friday, April 5, 2019)]
[Notices]
[Pages 13669-13670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06656]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-P-0047, FDA-2012-P-0468, FDA-2015-P-3400, and
FDA-2016-P-1667]
Determination That ANTIVERT Chewable Tablets, 25 Milligrams, and
Tablets, 12.5 Milligrams, 25 Milligrams, and 50 Milligrams, Were 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 ANTIVERT (meclizine hydrochloride) chewable tablets, 25
milligrams (mg), and tablets, 12.5 mg, 25 mg, and 50 mg, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Linda Jong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6288, Silver Spring, MD 20993-0002, 301-796-3977.
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
[[Page 13670]]
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, 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.
ANTIVERT (meclizine hydrochloride) chewable tablets, 25 mg, and
tablets, 12.5 mg, 25 mg, and 50 mg, are the subject of NDA 010721,
currently held by Casper Pharma LLC, and initially approved on February
14, 1957. ANTIVERT is indicated for the treatment of vertigo associated
with diseases affecting the vestibular system.
ANTIVERT (meclizine hydrochloride) chewable tablets, 25 mg, and
tablets, 12.5 mg, 25 mg, and 50 mg, are currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Since 2011, the Agency has received four citizen petitions,
submitted under 21 CFR 10.30, requesting that FDA determine whether one
or more dosage forms and strengths of ANTIVERT were withdrawn from sale
for reasons of safety or effectiveness.
InvaGen Pharmaceuticals submitted a citizen petition dated
January 14, 2011, and amendment dated February 24, 2011 (Docket No.
FDA-2011-P-0047), requesting that the Agency determine whether ANTIVERT
(meclizine hydrochloride) chewable tablets, 25 mg, was withdrawn from
sale for reasons of safety or effectiveness.
Modavar Pharmaceuticals LLC submitted a citizen petition
dated May 4, 2012, (Docket No. FDA-2012-P-0468) requesting that the
Agency determine whether ANTIVERT (meclizine hydrochloride) tablets,
12.5 mg and 25 mg, were withdrawn from sale for reasons of safety or
effectiveness.
Lupin Pharmaceuticals, Inc. submitted a citizen petition
dated September 18, 2015 (Docket No. FDA-2015-P-3400), requesting that
the Agency determine whether ANTIVERT (meclizine hydrochloride)
tablets, 12.5 mg, 25 mg, and 50 mg, were withdrawn from sale for
reasons of safety or effectiveness.
Zydus Pharmaceuticals submitted a citizen petition dated
June 14, 2016 (Docket No. FDA-2016-P-1667), requesting that the Agency
determine whether ANTIVERT (meclizine hydrochloride) tablets, 12.5 mg
and 25 mg, were withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petitions and reviewing Agency
records, and based on the information we have at this time, FDA has
determined under Sec. 314.161 that ANTIVERT (meclizine hydrochloride)
chewable tablets, 25 mg, and tablets, 12.5 mg, 25 mg, and 50 mg, were
not withdrawn for reasons of safety or effectiveness. The petitioners
have identified no data or other information suggesting that these drug
products were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
ANTIVERT (meclizine hydrochloride) chewable tablets, 25 mg, and
tablets, 12.5 mg, 25 mg, and 50 mg, from sale. We have also
independently evaluated relevant literature and data for possible post
marketing adverse events. We have found no information that would
indicate that these drug products were withdrawn from sale for reasons
of safety or effectiveness. Accordingly, the Agency will continue to
list ANTIVERT (meclizine hydrochloride) chewable tablets, 25 mg, and
tablets, 12.5 mg, 25 mg, and 50 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to these drug products. Additional ANDAs for
these drug products may also 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 these drug products should
be revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.
Dated: April 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-06656 Filed 4-4-19; 8:45 am]
BILLING CODE 4164-01-P