[Federal Register Volume 69, Number 163 (Tuesday, August 24, 2004)]
[Notices]
[Pages 52017-52018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19287]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003P-0548]


Determination That DECADRON-LA (Dexamethasone Acetate Injection), 
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 
DECADRON-LA (dexamethasone acetate injection), 8 milligrams (mg)/
milliliter (mL), was not withdrawn from sale for reasons of safety or 
effectiveness. As a result of this determination, FDA may approve 
abbreviated new drug applications (ANDAs) for dexamethasone acetate 
injection, 8 mg/mL.

FOR FURTHER INFORMATION CONTACT: Howard P. Muller, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20855, 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 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 Under FDA regulations, drugs are withdrawn from the list if the 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), 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. If the agency determines that a listed drug was withdrawn for 
reasons of safety or effectiveness, the drug must be removed from the 
list of approved drug products, and ANDAs referencing that drug may not 
be approved (Sec.  314.162).
    DECADRON-LA (dexamethasone acetate injection), 8 mg/mL, is the 
subject of approved NDA 16-675 held by Merck. In a letter to the agency 
dated June 25, 2002, Merck requested that NDA 16-675 be withdrawn 
because the drug is no longer marketed. Merck noted that the NDA was 
not withdrawn because of safety reasons. On December 5, 2003, Gray Cary 
submitted a citizen petition (Docket No. 2003P-0548/CP1) to FDA under 
21 CFR 10.30 requesting that the agency determine whether DECADRON-LA 
(dexamethasone acetate injection), 8 mg/mL, NDA 16-675, was withdrawn 
from sale for reasons of safety or effectiveness.
    The agency has determined that DECADRON-LA (dexamethasone acetate 
injection), 8 mg/mL, was not withdrawn from sale for reasons of

[[Page 52018]]

safety or effectiveness. FDA has independently evaluated relevant 
literature and data for possible postmarketing adverse event reports 
associated with this drug 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 its records, 
FDA determines that, for the reasons outlined previously, DECADRON-LA 
(dexamethasone acetate injection), 8 mg/mL, was not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
continue to list DECADRON-LA (dexamethasone acetate injection), 8 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 
DECADRON-LA (dexamethasone acetate injection), 8 mg/mL, may be approved 
by the agency.

    Dated: August 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-19287 Filed 8-23-04; 8:45 am]
BILLING CODE 4160-01-S