[Federal Register: August 24, 2004 (Volume 69, Number 163)]
[Notices]
[Page 52017-52018]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au04-57]
-----------------------------------------------------------------------
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Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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milliliter (mL), was not withdrawn from sale for reasons of safety or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 Under FDA regulations, drugs are withdrawn from the list if the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