Document ID: FDA-2013-N-0320-0001
Agency: fda
Document Type: Notice
Title: Determinations That BENADRYL (diphenhydramine hydrochloride) Injection and Two Other Drug Products Were Not Withdrawn From Sale For Reasons of Safety or Effectiveness
Posted Date: 2013-03-25T04:00Z

[Federal Register Volume 78, Number 57 (Monday, March 25, 2013)]
[Notices]
[Pages 17933-17934]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06726]

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

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Injection and Two Other Drug Products Were Not Withdrawn From Sale for 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.

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

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three drug products listed in this document were not withdrawn from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.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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