[Federal Register Volume 84, Number 136 (Tuesday, July 16, 2019)]
[Notices]
[Pages 33951-33952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15089]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-0372]


Determination That MIOCHOL (Acetylcholine Chloride Intraocular 
Solution), 20 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons 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, Agency, or we) has 
determined that MIOCHOL (acetylcholine chloride intraocular solution), 
20 milligrams (mg)/vial, was not withdrawn from sale for reasons of 
safety or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for acetylcholine chloride 
intraocular solution, 20 mg/vial, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Meadow Platt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-
796-1830.

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

[[Page 33952]]

do not have to repeat the 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.
    MIOCHOL (acetylcholine chloride intraocular solution), 20 mg/vial, 
is the subject of NDA 016211, held by Novartis Pharmaceutical 
Corporation (Novartis). MIOCHOL is indicated to obtain complete miosis 
of the iris in seconds after delivery of the lens in cataract surgery, 
in penetrating keratoplasty, iridectomy, and other anterior segment 
surgery where rapid, complete miosis may be required.
    In a letter dated January 18, 2006, Novartis requested withdrawal 
of NDA 016211 for MIOCHOL (acetylcholine chloride intraocular 
solution). In the Federal Register of July 12, 2018 (83 FR 32305), FDA 
announced that it was withdrawing approval of NDA 016211, effective 
August 13, 2018.
    Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated 
January 23, 2019, under 21 CFR 10.30, requesting that the Agency 
determine whether MIOCHOL (acetylcholine chloride intraocular 
solution), 20 mg/vial, 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 MIOCHOL (acetylcholine chloride intraocular 
solution), 20 mg/vial, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that MIOCHOL (acetylcholine chloride intraocular 
solution), 20 mg/vial, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of MIOCHOL (acetylcholine chloride 
intraocular solution), 20 mg/vial, from sale. We have also 
independently evaluated relevant literature and data for possible 
postmarketing adverse events. We have reviewed the available evidence 
and determined that this drug product was not withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list MIOCHOL 
(acetylcholine chloride intraocular solution), 20 mg/vial, 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 MIOCHOL 
(acetylcholine chloride intraocular solution), 20 mg/vial, 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: July 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15089 Filed 7-15-19; 8:45 am]
BILLING CODE 4164-01-P


