[Federal Register Volume 69, Number 220 (Tuesday, November 16, 2004)]
[Notices]
[Pages 67147-67148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25332]


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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1.0% Topical Solutions Were Not Withdrawn From Sale for Reasons of 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were not withdrawn from sale for reasons of safety or effectiveness.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