[Federal Register Volume 67, Number 250 (Monday, December 30, 2002)]
[Notices]
[Pages 79640-79641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32851]


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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Determination That Diazepam Autoinjector Was Not Withdrawn From 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(mg/mL) was not withdrawn from sale for reasons of safety or 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 Under FDA regulations, drugs are withdrawn from the list if the 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