[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]


-----------------------------------------------------------------------

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Release Tablets, 60 Milligrams, Were Not Withdrawn From Sale for 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.

-----------------------------------------------------------------------

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tablets, 60 milligrams (mg), were not withdrawn from sale for reasons 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