Determination That NILSTAT (Nystatin Powder (Oral, 100%)) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 11487-11488 [2011-4595]
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emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices
anticipate manufacturing dissolvable
tobacco products will take
approximately 1 hour to draft and send
a letter to FDA indicating that they do
not have documents to submit. These
estimates were derived based upon FDA
experience and feedback provided by
public and stakeholder comments.
The capital costs associated with this
collection pertain to the postage for
mailing documents in electronic or
paper formats. Estimating these costs is
problematic because the costs will vary
depending on the size of the document
production (e.g. one binder of
documents vs. numerous boxes of
paper) and the media type (e.g., compact
disk (CD) or digital video disk) chosen
to submit documents. Currently, we
cannot identify how many documents
will be submitted per response.
Some sample postage costs are shown
for different types of packages:
• 10 CDs in a flat envelope weighing
30 ounces: approximately $8.00 using
first class business mail
• 5-pound parcel containing paper
documents: approximately $12 using
business parcel post mail and delivering
to the furthest delivery zone
• 10-pound parcel containing paper
documents: approximately $17 using
business parcel mail and delivering to
the furthest delivery zone
• 50-pound parcel containing paper
documents: approximately $52 using
business parcel post mail and delivering
to the furthest delivery zone.
FDA estimates the capital costs
associated with this document
submission to be $924. The capital costs
determined by this estimate are based
upon 3 submissions for large
manufacturers, 7 submissions for small
to medium manufacturers, and 110
submissions of 1 letter apiece for those
who do not either manufacture
dissolvable tobacco products or have
documents pertaining to the
manufacture of dissolvable tobacco
products.
For the three large manufacturers, it is
estimated that each manufacturer will
submit their documents electronically
on the equivalent of one 500-gigabyte
external hard drive of data. This is
estimated to cost approximately $125
per drive, and $20 to ship the drive, for
a total of $435 (3 manufacturers × [$125
+ $20]).
For the 7 small to medium sized
manufacturers, it is estimated that 5
manufacturers (about 71 percent) will
submit their documents electronically
on the equivalent of 10 CD–ROMs. This
is estimated to cost $20 for the 10 CD–
ROM spindle, and $8 to ship each group
of 10 CDs per envelope for a total of
$140 (5 manufacturers × [$20 + $8]). The
VerDate Mar<15>2010
16:34 Mar 01, 2011
Jkt 223001
remaining two manufacturers will
submit their documents via paper,
which is estimated to cost $184 (2
manufacturers × [$40 cost of one box of
paper + $52 to ship the box of paper]).
The total capital cost for small to
medium manufacturers, therefore, is
estimated to be $324 ($140 + $184).
For the remaining 110 manufacturers
who must submit a letter to FDA
indicating that they do not have any
documents, it is estimated that each
manufacturer will use $1 of paper
products and pay postage
approximating a rounded figure of $0.50
for a total of $165 (110 manufacturers ×
[$1.00 + $0.50]). Therefore, FDA
estimates the total capital costs
associated with this document
submission to be $924.
Dated: February 24, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–4613 Filed 3–1–11; 8:45 am]
BILLING CODE 4160–01–P
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.
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
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
11487
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 § 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 § 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
E:\FR\FM\02MRN1.SGM
02MRN1
11488
Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0318]
Determination That MEGACE
(Megestrol Acetate) Tablets and Nine
Other Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that the 10 drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308,
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
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 (the
FD&C 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 withdrawn 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 § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved; (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved; and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for reasons of
safety or effectiveness, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
(As requested by the applicants, FDA
withdrew approval of NDA 18–101 for
SYMMETREL (amantadine
hydrochloride (HCl)) Tablets and ANDA
84–935 for DEXEDRINE
(dextroamphetamine sulfate) Tablets in
the Federal Register of July 21, 2010 (75
FR 42455).)
Drug
Applicant
NDA 16–979 ..............
NDA 17–911 ..............
MEGACE (megestrol acetate) Tablets, 20 milligrams (mg)
and 40 mg.
CLINORIL (sulindac) Tablet, 150 mg ...................................
NDA 18–101 ..............
emcdonald on DSK2BSOYB1PROD with NOTICES
Application No.
SYMMETREL (amantadine HCl) Tablet, 100 mg ................
NDA
NDA
NDA
NDA
PROCARDIA (nifedipine) Capsule, 20 mg ..........................
VEPESID (etoposide) Injection, 20 mg/milliliter (mL) ..........
TAXOL (paclitaxel) Injection, 6 mg/mL ................................
CEREBYX (fosphenytoin sodium) Injection, Equivalent to
(EQ) 50 mg phenytoin sodium/mL.
DURICEF (cefadroxil/cefadroxil hemihydrate) Oral Suspension, EQ 250 mg base/5mL and EQ 500 mg base/5 mL.
DEXTROSTAT (dextroamphetamine sulfate) Tablets, 5 mg
and 10 mg.
Bristol Myers Squibb, P.O. Box 4000, Princeton, NJ
08543–4000.
Merck Research Laboratories, Sumneytown Pike, West
Point, PA 19486.
Endo Pharmaceuticals, Inc., 100 Endo Blvd., Chadds
Ford, PA 19317.
Pfizer Inc., 235 East 42nd St., New York, NY 10017–5755.
Bristol Myers Squibb.
Do.
Parke Davis, 2800 Plymouth Rd., Ann Arbor, MI 48106–
1047.
Warner Chilcott, Inc., 100 Enterprise Dr., Suite 280, Rockaway, NJ 07866.
Shire Development, Inc., 725 Chesterbrook Blvd., Wayne,
PA 19087.
18–482
18–768
20–262
20–450
..............
..............
..............
..............
NDA 50–527 ..............
ANDA 84–051 ............
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02MRN1
]]>Agencies
[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11487-11488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4595]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
