[Federal Register: March 15, 2004 (Volume 69, Number 50)]
[Notices]
[Page 12158]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr04-67]
-----------------------------------------------------------------------
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(5 Milligrams/Milliliter in a 1-Milliliter Container) Was Not Withdrawn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.
-----------------------------------------------------------------------
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milliliter (mg/mL) in a 1-mL container) was not withdrawn from sale for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 Under FDA regulations, drugs are withdrawn from the list if the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