[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Pages 10493-10494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04726]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-5946]
Determination That DORYX MPC (Doxycycline Hyclate), Delayed-
Release Tablets, 60 Milligrams, Were Not Withdrawn From Sale for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 or Agency) has
determined that DORYX MPC (doxycycline hyclate), delayed-release
tablets, 60 milligrams (mg), were not withdrawn from sale for reasons
of safety or effectiveness. This determination will allow FDA to
approve abbreviated new drug applications (ANDAs) for DORYX MPC
(doxycycline hyclate), delayed-release tablets, 60 mg, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Aaron Young, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 301-
796-8083.
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drug was withdrawn from sale for reasons of safety or effectiveness
(Sec. 314.162 (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.
DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 mg,
are the subject of NDA 50-795, held by Mayne Pharma International Pty
Ltd., and initially approved on May 6, 2005. DORYX MPC is indicated for
rickettsial infections; sexually transmitted infections; respiratory
tract infections; specific bacterial infections; ophthalmic infections;
anthrax, including inhalational anthrax (post-exposure); alternative
treatment for selected infections when penicillin is contraindicated;
adjunctive therapy in acute intestinal amebiasis and severe acne; and
prophylaxis of malaria.
Mayne Pharma International Pty Ltd. has never marketed DORYX MPC
(doxycycline hyclate), delayed-release tablets, 60 mg. In previous
instances (see, e.g., 72 FR 9763 (March 5, 2007) and 61 FR 25497 (May
21, 1996)), the Agency has determined that, for
[[Page 10494]]
purposes of Sec. Sec. 314.161 and 314.162, never marketing an approved
drug product is equivalent to withdrawing the drug from sale.
Goodwin Procter LLP submitted a citizen petition dated September
26, 2017 (Docket No. FDA-2017-P-5946), under 21 CFR 10.30, requesting
that the Agency determine whether DORYX MPC (doxycycline hyclate),
delayed-release tablets, 60 mg, were 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 DORYX MPC (doxycycline hyclate), delayed-
release tablets, 60 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that this drug product was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of DORYX MPC (doxycycline hyclate),
delayed-release tablets, 60 mg, from sale. We have found no information
that would indicate that this drug product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list DORYX MPC
(doxycycline hyclate), delayed-release tablets, 60 mg, 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 this drug product 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: March 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04726 Filed 3-8-18; 8:45 am]
BILLING CODE 4164-01-P