[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Solution), 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or 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withdrawn from sale for reasons of safety or effectiveness.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drug was withdrawn from sale for reasons of safety or effectiveness (21 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