[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Notices]
[Page 27971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11285]
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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Solution), 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or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.
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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withdrawn from sale for reasons of safety or effectiveness.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drug was withdrawn from sale for reasons of safety or effectiveness (21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