[Federal Register: November 16, 2004 (Volume 69, Number 220)]
[Notices]
[Page 67147-67148]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no04-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004P-0051]
Determination That DYCLONE (Dyclonine Hydrochloride) 0.5% and
1.0% Topical Solutions Were Not Withdrawn From Sale for Reasons of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
DYCLONE (dyclonine hydrochloride (HCl)) 0.5% and 1.0% Topical Solutions
were not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for DYCLONE HCl 0.5 and 1.0% Topical Solutions.
FOR FURTHER INFORMATION CONTACT: Mary Catchings, 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. 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 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listed drug was withdrawn from sale for reasons of safety or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).
[[Page 67148]]
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.
DYCLONE (dyclonine HCl) 0.5% and 1.0% Topical Solutions were the
subject of approved NDA 9-925 held by AstraZeneca LP. DYCLONE Topical
Solutions were labeled for anesthetizing accessible mucus membranes
prior to various endoscopic procedures. DYCLONE 0.5% Topical Solution
was also labeled to block the gag reflex, to relieve the pain of oral
ulcers or stomatitis, and to relieve pain associated with ano-genital
lesions.
In a citizen petition dated February 3, 2004 (Docket No. 2004P-
0051/CP1), submitted under 21 CFR 10.25(a) and 10.30, Arent Fox, PLLC,
requested that the agency determine whether DYCLONE (dyclonine HCl)
0.5% and 1.0% Topical Solutions were withdrawn from the market for
reasons of safety or effectiveness. In the Federal Register of February
11, 2002 (67 FR 6264), FDA withdrew approval of NDA 9-925 for DYCLONE
0.5% and 1.0% Topical Solutions after AstraZeneca notified the agency
that DYCLONE was no longer being marketed under NDA 9-925 and requested
withdrawal of that application.
The agency has determined that DYCLONE 0.5% and 1.0% Topical
Solutions were not withdrawn from sale for reasons of safety or
effectiveness. The petitioner identified no data or other information
suggesting that DYCLONE was withdrawn from sale as a result of safety
or effectiveness concerns. FDA has independently evaluated relevant
literature and data for adverse event reports and has found no
information that would indicate that these products were withdrawn from
sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing agency
records, FDA determines that, for the reasons outlined in this notice,
dyclonine HCl 0.5% and 1.0% topical solutions approved under NDA 9-925
were not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list DYCLONE (dyclonine HCl)
0.5% and 1.0% Topical Solutions 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 DYCLONE (dyclonine HCl) 0.5% and
1.0% Topical Solutions may be approved by the agency.
Dated: November 8, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-25332 Filed 11-15-04; 8:45 am]
BILLING CODE 4160-01-S