[Federal Register Volume 72, Number 132 (Wednesday, July 11, 2007)]
[Notices]
[Pages 37784-37785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13416]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006P-0218]


Determination That ARISTOCORT FORTE Injectable Suspension 
(Triamcinolone Diacetate), 40 Milligrams per 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 
ARISTOCORT FORTE Injectable Suspension (triamcinolone diacetate), 40 
milligrams (mg) per milliliter (mL), was not withdrawn from sale for 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 triamcinolone 
diacetate suspension, 40 mg/mL.

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 Under FDA regulations, drugs are withdrawn from the list if the 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 (21 
CFR 314.162).
    Under 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.

[[Page 37785]]

    ARISTOCORT FORTE Injectable Suspension (triamcinolone diacetate), 
40 mg/mL, is the subject of approved NDA 12-802 currently held by 
Sandoz Canada Inc., a Novartis AG company (Sandoz). Triamcinolone 
diacetate suspension (40 mg/mL) is a synthetic glucocorticoid for use 
as an anti-inflammatory or immunosuppressant agent. Sandoz ceased 
manufacturing ARISTOCORT FORTE Injectable Suspension (triamcinolone 
diacetate), 40 mg/mL, in March 2004. West-ward Pharmaceutical Corp. 
submitted a citizen petition dated May 22, 2006 (Docket No. 2006P-0218/
CP1), under 21 CFR 10.30, requesting that the agency determine whether 
triamcinolone diacetate suspension, 40 mg/mL, was withdrawn from sale 
for reasons of safety or effectiveness.
    The agency has determined that ARISTOCORT FORTE Injectable 
Suspension (triamcinolone diacetate), 40 mg/mL, was not withdrawn from 
sale for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that triamcinolone 
diacetate suspension, 40 mg/mL, was withdrawn 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 this product was withdrawn for reasons 
of safety or effectiveness.
    After considering the citizen petition and reviewing agency 
records, FDA determines that for the reasons outlined previously in 
this document, ARISTOCORT FORTE Injectable Suspension (triamcinolone 
diacetate), 40 mg/mL, was not withdrawn from sale for reasons of safety 
or effectiveness. Accordingly, the agency will continue to list 
ARISTOCORT FORTE Injectable Suspension (triamcinolone diacetate), 40 
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 
ARISTOCORT FORTE Injectable Suspension (triamcinolone diacetate), 40 
mg/mL, may be approved by the agency as long as they meet all relevant 
legal and regulatory requirements for the approval of ANDAs. If FDA 
determines that labeling for these drug products should be revised to 
meet current standards, the agency will advise ANDA applicants to 
submit such labeling.

    Dated: June 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13416 Filed 7-10-07; 8:45 am]
BILLING CODE 4160-01-S