[Federal Register Volume 78, Number 57 (Monday, March 25, 2013)]
[Notices]
[Pages 17933-17934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06726]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0320]
Determination That BENADRYL (diphenhydramine hydrochloride)
Injection and Two Other Drug Products Were Not Withdrawn From Sale for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) has determined that the
three drug products listed in this document were not withdrawn from
[[Page 17934]]
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 these drug products, and it
will allow FDA to continue to approve ANDAs that refer to the products
as long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Mark Geanacopoulos, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 301-
796-6925.
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
sponsors 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. Sponsors of ANDAs do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
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 products listed in the table in
this document are no longer being marketed.
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Application No. Drug Applicant
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NDA 006146............. BENADRYL McNeil Consumer
(diphenhydramine Healthcare, 7050 Camp
hydrochloride) Hill Rd., Fort
Injection, 50 Washington, PA 19034.
milligrams (mg)/
milliliter (mL).
NDA 009486............. BENADRYL PRESERVATIVE Do.
FREE (diphenhydramine
hydrochloride)
Injection, 50 mg/mL.
NDA 017821............. FLEXERIL Janssen Research &
(cyclobenzaprine Development, LLC, 920
hydrochloride) Rt. 202, Raritan, NJ
Tablets, 5 mg and 10 08869.
mg.
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FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products 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 NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs that refer to these products may also be
approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: March 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06726 Filed 3-22-13; 8:45 am]
BILLING CODE 4160-01-P