[Federal Register: December 30, 2002 (Volume 67, Number 250)]
[Notices]
[Page 79640-79641]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de02-104]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01P-0542]
Determination That Diazepam Autoinjector Was Not Withdrawn From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 Autoinjector (diazepam for injection) 5 milligrams per
milliliter
[[Page 79641]]
(mg/mL) was not withdrawn from sale for reasons of safety or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 for injection 5 mg/mL.
FOR FURTHER INFORMATION CONTACT: J. Kenneth Borgerding, 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 a
version of the drug that was previously approved under a new drug
application (NDA). Sponsors of ANDAs do not have to repeat the
extensive clinical testing otherwise necessary to gain approval of an
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 Under FDA regulations, drugs are withdrawn from the list if the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listed drug was withdrawn from sale for reasons of safety or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) (21 CFR 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 Autoinjector is the subject of NDA 20-124. Diazepam
Autoinjector is an automatic injection drug product indicated for the
management of anxiety disorders and the treatment of epileptic and
other convulsive seizures. FDA approved NDA 20-124, held by the U.S.
Army (Army), on December 5, 1990. The Diazepam Autoinjector is
manufactured for the Army by Meridian Medical Technologies, Inc. (MMT),
and has always been listed in the ``Discontinued Drug Product List'' of
the Orange Book because it is not commercially available.
On November 30, 2001, MMT submitted a citizen petition (Docket No.
01P-0542/CP1) under 21 CFR 10.30 requesting that the agency determine
whether Diazepam Autoinjector was withdrawn from sale for reasons of
safety or effectiveness.
The agency has determined that Diazepam Autoinjector was not
withdrawn from sale for reasons of safety or effectiveness. The Army
has never commercially marketed Diazepam Autoinjector. In previous
instances (see, e.g., 61 FR 25497, May 21, 1996 (addressing a relisting
request for glyburide tablets)), FDA has concluded that, for purposes
of Sec. Sec. 314.161 and 314.162, never marketing an approved drug
product is equivalent to withdrawing the drug from sale. There is no
indication that the Army's decision not to market Diazepam Autoinjector
commercially is a function of safety or effectiveness concerns, and the
petitioner has identified no data or other information suggesting that
Diazepam Autoinjector poses a safety risk. FDA's independent evaluation
of relevant information has uncovered nothing that would indicate this
product was withdrawn for reasons of safety or effectiveness.
After considering the citizen petition and reviewing agency
records, FDA has determined that, for the reasons outlined previously,
Diazepam Autoinjector was not withdrawn from sale for reasons of safety
or effectiveness. Accordingly, the agency will continue to list
Diazepam Autoinjector (diazepam for injection) 5 mg/mL 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 Autoinjector
(diazepam for injection) 5 mg/mL may be approved by the agency.
Dated: December 19, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32851 Filed 12-27-02; 8:45 am]
BILLING CODE 4160-01-S