Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 27971 [2013-11285]
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Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Notices
these estimates were made. We use this
estimate consistently throughout the
table and calculate the ‘‘total annual
responses’’ by multiplying the number
of responses per respondent by the
number of respondents.
Dated: May 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–11273 Filed 5–10–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–P–1000]
Determination That REV–EYES
(Dapiprazole Hydrochloride
Ophthalmic Solution), 0.5%, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that REV–EYES (dapiprazole
hydrochloride ophthalmic solution),
0.5%, was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for dapiprazole
hydrochloride ophthalmic solution,
0.5%, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
David E. Markert, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3602.
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).
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:13 May 10, 2013
Jkt 229001
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
REV–EYES (dapiprazole
hydrochloride ophthalmic solution),
0.5%, is the subject of NDA 19–849,
held by Angelini Pharmaceuticals Inc.,
and initially approved on December 31,
1990. REV–EYES is indicated for the
treatment of iatrogenically induced
mydriasis produced by adrenergic
(phenylephrine) or parasympatholytic
(tropicamide) agents.
REV–EYES (dapiprazole
hydrochloride ophthalmic solution),
0.5%, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
CUSTOpharm, Inc., submitted a
citizen petition dated September 11,
2012 (Docket No. FDA–2012–P–1000),
under 21 CFR 10.30, requesting that the
Agency determine whether REV–EYES
(dapiprazole hydrochloride ophthalmic
solution), 0.5%, 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
§ 314.161 that REV–EYES (dapiprazole
hydrochloride ophthalmic solution),
0.5%, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that REV–EYES
(dapiprazole hydrochloride ophthalmic
solution), 0.5%, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
REV–EYES (dapiprazole hydrochloride
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
27971
ophthalmic solution). 0.5%. 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 product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list REV–EYES (dapiprazole
hydrochloride ophthalmic solution),
0.5%, 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 REV–EYES
(dapiprazole hydrochloride ophthalmic
solution), 0.5%, 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: May 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–11285 Filed 5–10–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0677]
Dental Products Panel of the Medical
Devices Advisory Committee; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Dental Products
Panel of the Medical Devices Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 18th, 2013, from 8 a.m. to
2:30 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B and C,
620 Perry Pkwy., Gaithersburg, MD,
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Notices]
[Page 27971]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11285]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-P-1000]
Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic
Solution), 0.5%, 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) has determined that
REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for dapiprazole hydrochloride ophthalmic solution,
0.5%, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: David E. Markert, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3602.
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, 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.
REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, is
the subject of NDA 19-849, held by Angelini Pharmaceuticals Inc., and
initially approved on December 31, 1990. REV-EYES is indicated for the
treatment of iatrogenically induced mydriasis produced by adrenergic
(phenylephrine) or parasympatholytic (tropicamide) agents.
REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, is
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book.
CUSTOpharm, Inc., submitted a citizen petition dated September 11,
2012 (Docket No. FDA-2012-P-1000), under 21 CFR 10.30, requesting that
the Agency determine whether REV-EYES (dapiprazole hydrochloride
ophthalmic solution), 0.5%, 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 REV-EYES (dapiprazole hydrochloride ophthalmic
solution), 0.5%, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that REV-EYES (dapiprazole hydrochloride
ophthalmic solution), 0.5%, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of REV-EYES (dapiprazole hydrochloride
ophthalmic solution). 0.5%. 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 product was withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list REV-EYES (dapiprazole
hydrochloride ophthalmic solution), 0.5%, 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 REV-EYES (dapiprazole hydrochloride
ophthalmic solution), 0.5%, 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: May 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11285 Filed 5-10-13; 8:45 am]
BILLING CODE 4160-01-P
