[Federal Register Volume 69, Number 50 (Monday, March 15, 2004)]
[Notices]
[Page 12158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003P-0393]


Determination That DIAZEPAM Injection United States Pharmacopeia 
(5 Milligrams/Milliliter in a 1-Milliliter Container) Was Not Withdrawn 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) has determined that 
DIAZEPAM Injection United States Pharmacopeia (USP) (5 milligrams/
milliliter (mg/mL) in a 1-mL container) was not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for DIAZEPAM 
Injection USP (5 mg/mL in a 1-mL container).

FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

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 
typically 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 Under FDA regulations, drugs are withdrawn from the list if the 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).
    Under Sec.  314.161(a)(1), the agency must determine whether a 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness before an ANDA that refers to that listed drug may be 
approved. FDA may not approve an ANDA that does not refer to a listed 
drug.
    DIAZEPAM Injection USP (5 mg/mL in a 1-mL container) is the subject 
of approved ANDA 72-079 held by Abbott Laboratories, Inc. (Abbott). 
DIAZEPAM Injection USP (5 mg/mL in a 1-mL container) is indicated for 
the management of anxiety disorders or for the short-term relief of the 
symptoms of anxiety. PharmaForce, Inc., submitted a citizen petition 
dated August 25, 2003 (Docket No. 2003P-0393/CP1), under 21 CFR 10.30, 
requesting that the agency determine whether DIAZEPAM Injection USP (5 
mg/mL, 1 mL) was withdrawn from sale for reasons of safety or 
effectiveness.
    The agency has determined that DIAZEPAM Injection USP in a 5-mg 
strength (5 mg/mL in a 1-mL container) was not withdrawn from sale for 
reasons of safety or effectiveness. Two grounds support the agency's 
finding. First, DIAZEPAM Injection USP currently is being marketed in a 
10-mg strength (5 mg/mL in a 2-mL container). Adverse drug events would 
be less likely with the discontinued lower dose than the currently 
marketed higher dose. In addition, by using only a portion of the 
amount currently marketed, the 5-mg strength in question still can be 
obtained. Second, the lower 5-mg strength of DIAZEPAM Injection USP 
would be considered an effective dosage form because it is still within 
the dosing range. The usual recommended dose for older children and 
adults ranges from 2 to 20 mg intramuscularly or intraveneously, 
depending on the indication and its severity.
    After considering the citizen petition and reviewing its records, 
FDA determines that, for the reasons outlined previously, DIAZEPAM 
Injection, USP (5 mg/mL in a 1-mL container) was not withdrawn from 
sale for reasons of safety or effectiveness. Accordingly, the agency 
will continue to list DIAZEPAM Injection USP (5 mg/mL in a 1-mL 
container) 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 
DIAZEPAM Injection USP (5 mg/mL, 1 mL) may be approved by the agency.

    Dated: March 8, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5756 Filed 3-12-04; 8:45 am]
BILLING CODE 4160-01-S