[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33757-33758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13757]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-P-0136 (Formerly Docket No. 2006P-0496) and Docket 
No. FDA-2007-P-0353 (Formerly Docket No. 2007P-0034)]


Determination That AZO GANTANOL (Phenazopyridine Hydrochloride, 
Sulfamethoxazole) Tablet, 100 Milligrams/500 Milligrams, and AZO 
GANTRISIN (Phenazopyridine Hydrochloride, Sulfisoxazole) Tablet, 50 
Milligrams/500 Milligrams, Were Not Withdrawn From Sale for Reasons of 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) is announcing its 
determination that AZO GANTANOL (phenazopyridine hydrochloride (HCl) 
and sulfamethoxazole) Tablet, 100 milligrams (mg)/500 mg, and AZO 
GANTRISIN (phenazopyridine HCl and sulfisoxazole) Tablet, 50 mg/500 mg, 
were not withdrawn from sale for reasons of safety or effectiveness. 
This determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for phenazopyridine HCl and sulfamethoxazole 
tablet, 100 mg/500 mg, and phenazopyridine HCl and sulfisoxazole 
tablet, 50 mg/500 mg, if all other legal and regulatory requirements 
are met.

FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
applicants 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

[[Page 33758]]

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 known generally 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to FDA's approval of an ANDA that refers to the 
listed drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an 
ANDA that does not refer to a listed drug.
    AZO GANTANOL is the subject of NDA 013294, held by Roche and 
approved on April 8, 1965. AZO GANTRISIN is the subject of NDA 019358, 
held by Roche and initially approved on August 31, 1990. Under the Drug 
Efficacy Study Implementation (DESI), FDA concluded that a fixed 
combination drug product containing 500 mg of sulfamethoxazole and 100 
mg of phenazopyridine HCl, and certain other sulfonamide/
phenazopyridine combinations, are effective for indications described 
in a Federal Register notice published on July 29, 1983 (DESI 12056, 48 
FR 34516). Consistent with that determination, both AZO GANTANOL and 
AZO GANTRISIN are indicated for the initial treatment of uncomplicated 
urinary tract infections caused by susceptible strains of Escherichia 
coli, Klebsiella species, Enterobacter species, Proteus mirabilis, 
Proteus vulgaris, and Staphylococcus aureus when relief of symptoms of 
pain, burning, or urgency is needed during the first 2 days of therapy.
    In a letter dated May 29, 1998, Roche requested that FDA withdraw 
approval of NDA 013294 for AZO GANTANOL (phenazopyridine HCl and 
sulfamethoxazole) Tablet, 100 mg/500 mg. In the Federal Register of 
September 25, 1998 (63 FR 51359), FDA announced that it was withdrawing 
approval of NDA 013294 effective September 25, 1998.
    In a letter dated March 23, 1998, Roche requested that FDA withdraw 
approval of NDA 019358 for AZO GANTRISIN (phenazopyridine HCl and 
sulfisoxazole) Tablet, 50 mg/500 mg. In the Federal Register of May 12, 
1998 (63 FR 26191), FDA announced that it was withdrawing approval of 
NDA 019358 effective June 11, 1998.
    Vintage Pharmaceuticals, LLC, submitted a citizen petition dated 
December 1, 2006 (Docket No. FDA-2006-P-0136), under 21 CFR 10.30, 
requesting that FDA determine whether AZO GANTANOL and AZO GANTRISIN 
were withdrawn from sale for reasons of safety or effectiveness. 
JRRapoza Associates, Inc., submitted a citizen petition dated January 
17, 2007 (Docket No. FDA-2007-P-0353), under 21 CFR 10.30, also 
requesting that FDA determine whether AZO GANTANOL and AZO GANTRISIN 
were withdrawn from sale for reasons of safety or effectiveness.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that AZO GANTANOL (phenazopyridine HCl and sulfamethoxazole) 
Tablet, 100 mg/500 mg, and AZO GANTRISIN (phenazopyridine HCl and 
sulfisoxazole) Tablet, 50 mg/500 mg, were not withdrawn from sale for 
reasons of safety or effectiveness. We have also independently 
evaluated relevant literature and have found no information that would 
indicate that these products were withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list AZO GANTANOL 
(phenazopyridine HCl and sulfamethoxazole) Tablet, 100 mg/500 mg, and 
AZO GANTRISIN (phenazopyridine HCl and sulfisoxazole) Tablet, 50 mg/500 
mg, in the ``Discontinued Drug Product List'' section of the Orange 
Book. The ``Discontinued Drug Product List'' delineates, among other 
things, drug products that have been discontinued from marketing for 
reasons other than safety or effectiveness. ANDAs that refer to either 
AZO GANTANOL (phenazopyridine HCl and sulfamethoxazole) Tablet, 100 mg/
500 mg, or AZO GANTRISIN (phenazopyridine HCl and sulfisoxazole) 
Tablet, 50 mg/500 mg, may be approved by the Agency if all other legal 
and regulatory requirements for the approval of ANDAs are met. If FDA 
determines that the labeling for either drug product should be revised 
to meet current standards, the Agency will advise ANDA applicants to 
submit such labeling.

    Dated: June 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13757 Filed 6-11-14; 8:45 am]
BILLING CODE 4164-01-P