[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58489-58490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24622]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3393]
Determination That ORTHO EVRA (Norelgestromin/Ethinyl Estradiol)
Transdermal System, 0.15 Milligrams/24 Hours Norelgestromin and 0.035
Milligrams/24 Hours Ethinyl Estradiol, Was Not Withdrawn From Sale for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 Agency) has
determined that ORTHO EVRA (norelgestromin/ethinyl estradiol)
Transdermal System, 0.15 milligrams (mg)/24 hours (hr) norelgestromin
and 0.035 mg/24hr ethinyl estradiol was not withdrawn from sale for
reasons of safety or effectiveness. This determination means that FDA
will not begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to this drug product, and it will allow
FDA to continue to approve ANDAs that refer to the product as long as
they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-402-4191,
[email protected].
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain
[[Page 58490]]
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 generally known as the ``Orange
Book''. Under FDA regulations, a drug is 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).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
FDA has become aware that the drug product listed in the table in
this document is no longer being marketed.
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Application No. Drug Applicant
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NDA 21-180.................. ORTHO EVRA Janssen
(norelgestromin/ Pharmaceutical
ethinyl estradiol) Inc., 920 U.S.
Transdermal System; Highway 202,
0.15 mg/24hr Raritan, NJ 08869-
norelgestromin and 0602.
0.035 mg/24hr
ethinyl estradiol.
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FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug product listed in this document was not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug product listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDA listed in this document are
unaffected by the discontinued marketing of the product subject to this
NDA. Additional ANDAs that refer to this product may also be approved
by the Agency if they comply with relevant legal and regulatory
requirements. If FDA determines that labeling for norelgestromin/
ethinyl estradiol transdermal system should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
Dated: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24622 Filed 9-28-15; 8:45 am]
BILLING CODE 4164-01-P