[Federal Register Volume 75, Number 159 (Wednesday, August 18, 2010)]
[Notices]
[Pages 51080-51081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20327]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-P-0386]


Determination That DIASTAT (Diazepam Rectal Gel), 5 Milligrams/
Milliliter, 10 Milligrams/2 Milliliter, 15 Milligrams/3 Milliliter, and 
20 Milligrams/4 Milliliter, Was Not Withdrawn From Sale for Reasons of 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 
DIASTAT (diazepam rectal gel) (DIASTAT), 5 milligrams (mg)/milliliter 
(mL), 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, was not withdrawn from 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 rectal gel, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, 
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6312, Silver Spring, MD 20993-0002, 301-
796-3601.

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 removed from the list if the 
agency withdraws or suspends approval of the drug's NDA 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)(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.
    Lachman Consultant Services, Inc., submitted to FDA a citizen 
petition dated May 15, 2006 (Docket No. FDA-2006-P-0386),\1\ under 21 
CFR 10.30 requesting that the agency determine whether DIASTAT 
(diazepam rectal gel), 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, 
was withdrawn from sale for reasons of safety or effectiveness. DIASTAT 
(diazepam rectal gel) is the subject of approved NDA 20-648 held by 
Valeant Pharmaceuticals International (Valeant) (formerly held by Xcel 
Pharmaceuticals). DIASTAT (diazepam rectal gel) is an anticonvulsant 
agent indicated for use in the management of selected, refractory 
patients with epilepsy, on stable regimens of antiepileptic drugs, who 
require intermittent use of diazepam to control bouts of increased 
seizure activity.
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    \1\ This citizen petition was originally assigned docket number 
2006P-0209. The number changed to FDA-2006-P-0386 as a result of 
FDA's transition to its new docketing system (Regulations.gov) in 
January 2008.
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    DIASTAT (diazepam rectal gel) was approved on July 29, 1997 (NDA 
20-648). On September 15, 2005, FDA approved a supplement (NDA 20-648/
S-008) for a new delivery system of DIASTAT (diazepam rectal gel), 
marketed under the trade name DIASTAT ACUDIAL. Following approval of 
DIASTAT ACUDIAL, Valeant discontinued marketing DIASTAT (diazepam 
rectal gel) (NDA 20-648) in the 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 
mg/4 mL strengths, and those strengths of the product were moved to the 
``Discontinued Drug Product List'' section of the Orange Book. We note 
that the original DIASTAT (diazepam rectal gel) and DIASTAT ACUDIAL 
that replaced the original DIASTAT delivery system contain the same 
diazepam gel formulation. Thus, the original diazepam gel formulation 
is still being marketed, but in a different delivery system.
    After considering the citizen petitions, other information 
submitted to the docket, and reviewing our records, FDA has determined 
that DIASTAT (diazepam rectal gel), 5 mg/ mL, 10 mg/2 mL, 15 mg/3 mL, 
and 20 mg/4 mL, was not withdrawn from sale for reasons of safety or 
effectiveness. FDA has independently evaluated relevant literature and 
data for possible postmarketing adverse events and has found no 
information that would indicate that DIASTAT (diazepam rectal gel), 5 
mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, was withdrawn from sale 
for reasons of safety or effectiveness. Issues regarding the 
appropriateness of permitting ANDAs referencing the discontinued 
DIASTAT (diazepam rectal gel) to be marketed at the same time as 
DIASTAT ACUDIAL are being addressed in a separate docket (FDA-2006-P-
0009).
    Accordingly, the agency will continue to list DIASTAT (diazepam 
rectal gel), 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 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 DIASTAT (diazepam 
rectal gel), 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, may be 
approved by the agency if all other legal and regulatory requirements 
for the approval of ANDAs are met. If FDA determines that labeling for 
this drug product should be revised to meet current standards, the 
agency will advise ANDA applicants to submit such labeling.


[[Page 51081]]


    Dated: August 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-20327 Filed 8-17-10; 8:45 am]
BILLING CODE 4160-01-S