[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Solution), 20 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons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20 milligrams (mg)/vial, was not withdrawn from sale for reasons of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drug was withdrawn from sale for reasons of safety or effectiveness (21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