[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Withdrawn From Sale for Reasons of Safety or Effectiveness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NILSTAT (nystatin powder (oral, 100%)) was not withdrawn from sale for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