[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11487-11488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4595]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0201]


Determination That NILSTAT (Nystatin Powder (Oral, 100%)) 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 
NILSTAT (nystatin powder (oral, 100%)) was not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for nystatin 
powder (oral, 100%) if all other legal and regulatory requirements are 
met.

FOR FURTHER INFORMATION CONTACT: Jennifer L. Stevens, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6316, Silver Spring, MD 20993-0002, 301-
796-3602.

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 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 generally known as the ``Orange 
Book.'' Under FDA regulations, a drug is 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). Under Sec.  314.161(a)(1) (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.
    NILSTAT (nystatin powder (oral, 100%)) is the subject of NDA 
050576, held by Dava Pharmaceuticals, Inc., and was initially approved 
on December 22, 1983. NILSTAT is indicated for the treatment of 
intestinal and oral cavity infections caused by Candida (Monilia) 
albicans. NILSTAT (nystatin powder (oral, 100%)) is currently listed in 
the ``Discontinued Drug Product List'' section of the Orange Book.
    Paddock Laboratories, Inc., submitted a citizen petition dated 
April 8, 2010 (Docket No. FDA-2010-P-0201), under 21 CFR 10.30, 
requesting that the Agency determine whether NILSTAT (nystatin powder 
(oral, 100%)) 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 NILSTAT (nystatin 
powder (oral, 100%)) was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that NILSTAT (nystatin powder (oral, 100%)) was

[[Page 11488]]

withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of NILSTAT 
(nystatin powder (oral, 100%)) from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events and 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 NILSTAT (nystatin 
powder (oral, 100%)) 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 NILSTAT (nystatin powder (oral, 100%)) 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.

    Dated: February 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4595 Filed 3-1-11; 8:45 am]
BILLING CODE 4160-01-P