[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Notices]
[Pages 51575-51576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20634]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0886]


Determination That JADELLE (Levonorgestrel) Implant, 75 
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 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 or we) has determined 
that JADELLE (levonorgestrel) implant, 75 milligrams (mg), was not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for JADELLE (levonorgestrel) implant, 75 mg, if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455.

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drug was withdrawn from sale for reasons of safety or effectiveness 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.
    JADELLE (levonorgestrel) implant, 75 mg, is the subject of NDA 20-
544, held by Population Council, and initially approved on November 1, 
1996. JADELLE (levonorgestrel) implants, 75 mg, are indicated for the 
prevention of pregnancy and are a long-term (up to 5 years) reversible 
method of contraception.
    Population Council has never marketed JADELLE (levonorgestrel) 
implant, 75 mg. Therefore, as in previous instances (see e.g., 72 FR 
9763, 61 FR 25497), the Agency has determined, for purposes of 
Sec. Sec.  314.161 and 314.162, never marketing an approved drug 
product is equivalent to withdrawing the drug from sale.
    Arnall Golden Gregory, LLP submitted a citizen petition dated July

[[Page 51576]]

17, 2013 (Docket No. FDA-2013-P-0886), under 21 CFR 10.30, requesting 
that the Agency determine whether JADELLE (levonorgestrel) implant, 75 
mg, 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 JADELLE (levonorgestrel) implant, 75 mg, was 
not withdrawn for reasons of safety or effectiveness. The petitioner 
has identified no data or other information suggesting that JADELLE 
(levonorgestrel) implant, 75 mg, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of JADELLE (levonorgestrel) implant, 75 mg, 
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 JADELLE 
(levonorgestrel) implant, 75 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 JADELLE (levonorgestrel) implant, 75 
mg, 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: August 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-20634 Filed 8-28-14; 8:45 am]
BILLING CODE 4164-01-P