[Federal Register Volume 77, Number 84 (Tuesday, May 1, 2012)]
[Notices]
[Pages 25720-25721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10466]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0025]


Determination That GRIFULVIN V (Griseofulvin Microcrystalline) 
Tablets, 250 Milligrams, Was Not Withdrawn From Sale for Reasons of 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 
GRIFULVIN V (griseofulvin microcrystalline) tablets, 250 milligrams 
(mg), was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for griseofulvin microcrystalline 
tablets, 250 mg, if all other legal and regulatory requirements are 
met.

FOR FURTHER INFORMATION CONTACT: Nancy Hayes, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6244, 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 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 
the drug that was previously approved. ANDA applicants 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 approving 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.
    GRIFULVIN V (griseofulvin microcrystalline) tablets, 250 mg, is the 
subject of ANDA 062279, held by OrthoNeutrogena, and approved on June 
2, 1980. GRIFULVIN V is indicated for the treatment of certain ringworm 
infections (tinea corporis, tinea pedis, tinea cruris, tinea barbae, 
tinea capitis, and tinea unguium) when caused by a certain genera of 
fungi.
    GRIFULVIN V (griseofulvin microcrystalline) tablets, 250 mg, is 
currently listed in the ``Discontinued Drug Product List'' section of 
the Orange Book.
    Arthur Y. Tsien of Olsson Frank Weeda Terman Bode Matz PC submitted 
a citizen petition on behalf of a client, dated January 7, 2011 (Docket 
No. FDA-2011-P-0025), under 21 CFR 10.30, requesting that the Agency 
determine whether GRIFULVIN V (griseofulvin microcrystalline) tablets, 
250 mg, was withdrawn from sale for reasons of safety or effectiveness. 
After considering the citizen petition and reviewing Agency records, 
FDA has determined under Sec.  314.161 that GRIFULVIN V (griseofulvin 
microcrystalline) tablets, 250 mg, was not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that GRIFULVIN V (griseofulvin microcrystalline) 
tablets, 250 mg, was withdrawn for reasons of safety or effectiveness. 
We have carefully reviewed our files for records concerning the 
withdrawal of GRIFULVIN V (griseofulvin microcrystalline) tablets, 250 
mg, from sale. We have also independently reviewed relevant literature 
and data for possible postmarketing adverse event reports. We have 
found no information that would indicate that this product was 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list GRIFULVIN V 
(griseofulvin microcrystalline) tablets, 250 mg, 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 GRIFULVIN V (griseofulvin 
microcrystalline) tablets, 250 mg, may be approved by the Agency as 
long as they meet all other legal and regulatory requirements for the 
approval of ANDAs. If FDA determines that labeling for this drug 
product should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.


[[Page 25721]]


    Dated: April 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10466 Filed 4-30-12; 8:45 am]
BILLING CODE 4160-01-P