Determination That THORAZINE (Chlorpromazine Hydrochloride) Injection and 18 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 28255-28256 [E9-14000]
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Federal Register / Vol. 74, No. 113 / Monday, June 15, 2009 / Notices
Food and Drug Administration
[Docket No. FDA–2009–N–0254]
Determination That THORAZINE
(Chlorpromazine Hydrochloride)
Injection and 18 Other Drug Products
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that the 19 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document were not withdrawn from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.
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 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors 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. 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 (the 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a drug is withdrawn from the list if the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 20–225 for
IMDUR (isosorbide mononitrate)
Extended-Release Tablets in the Federal
Register of February 11, 2009 (74 FR
6896) and NDA 11–556 for ANTURANE
(sulfinpyrazone) Tablets and Capsules,
NDA 15–500 for TOLINASE
(tolazamide) Tablets, NDA 18–285 for
VISKEN (pindolol) Tablets, NDA 20–
137 for DEMADEX (torsemide)
Injection, and NDA 20–154 for VIDEX
(didanosine) Chewable Tablets in the
Federal Register of May 19, 2009 (74 FR
23407)).
Drug
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
28255
Applicant
Application No.
THORAZINE (chlorpromazine hydrochloride
(HCI)) Injection, 25 milligrams (mg)/milliliter
(mL)
GlaxoSmithKline, 2301 Renaissance Blvd.,
King of Prussia, PA 19406
NDA 9–149
THORAZINE (chlorpromazine HCl) Oral Concentrate, 30 mg/mL and 100 mg/mL
Do.
NDA 9–149
THORAZINE (chlorpromazine HCl) Oral
Syrup, 10 mg/5 mL
Do.
NDA 9–149
THORAZINE (chlorpromazine) Suppositories,
25 mg and 100 mg
Do.
NDA 11–552
STELAZINE (trifluoperazine HCl) Tablets,
Equivalent to (EQ) 1 mg base, EQ 2 mg
base, EQ 5 mg base, and EQ 10 mg base
Do.
NDA 11–556
ANTURANE (sulfinpyrazone) Tablet, 100 mg
Novartis Pharmaceuticals Corp., One Health
Plaza, East Hanover, NJ 07963
NDA 11–556
pwalker on PROD1PC71 with NOTICES
NDA 9–149
ANTURANE (sulfinpyrazone) Capsule, 200
mg
Do.
NDA 12–940
ISORDIL (isosorbide dinitrate) Sublingual
Tablets, 2.5 mg, 5 mg, and 10 mg
Biovail Pharmaceuticals, Inc., 700 Route
202–206 North, Bridgewater, NJ 08807–
0980
NDA 15–500
TOLINASE (tolazamide) Tablets, 100 mg,
250 mg, and 500 mg
Pfifzer, Inc., 235 East 42d St., New York, NY
10017
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16:47 Jun 12, 2009
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28256
Federal Register / Vol. 74, No. 113 / Monday, June 15, 2009 / Notices
Application No.
Drug
Applicant
NDA 18–154
LONITEN (minoxidil) Tablets, 2.5 mg and 10
mg
Pharmacia & Upjohn Co., c/o Pfizer, Inc.
NDA 18–285
VISKEN (pindolol) Tablets, 5 mg and 10 mg
Novartis Pharmaceuticals Corp.
NDA 18–445
DOLOBID (diflunisal) Tablets, 250 mg and
500 mg
Merck & Co., Inc., Sunneytown Pike, P.O.
Box 4, BLA–20, West Point, PA 19486
NDA 19–661
CYTOVENE IV (ganciclovir sodium) Injection,
EQ 500 mg base/vial
Roche Laboratories, Inc., 340 Kingsland St.,
Nutley, NJ 07110–1199
NDA 20–027
CARDIZEM (diltiazem HCl) Injection, 5 mg/
mL and 25 mg/vial
Biovail Pharmaecuticals, Inc.
NDA 20–137
DEMADEX (torsemide) Injection, 20 mg/2 mL
(10 mg/mL) and 50 mg/5 mL (10 mg/mL)
Roche Laboratories, Inc.
NDA 20–154
VIDEX (didanosine) Chewable Tablets, 25
mg, 50 mg, 100 mg, 150 mg, and 200 mg
Bristol-Myers Squibb Co., P.O. Box 5100,
Wallingford, CT 06492–7660
NDA 20–225
IMDUR (isosorbide mononitrate) ExtendedRelease Tablets, 30 mg, 60 mg, and 120
mg
Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033
NDA 21–238
KYTRIL (granisetron HCl) Oral Solution, EQ
2 mg base/10 mL
Roche Laboratories, Inc.
NDA 21–301
LEVOXYL (levothyroxine sodium) Tablet, 0.3
mg
King Pharmaceuticals, Inc., 501 Fifth St.,
Bristol, TN 37620
pwalker on PROD1PC71 with NOTICES
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs listed in this document are
unaffected by the discontinued
marketing of the products subject to
those NDAs. Additional ANDAs that
refer to these products may also be
approved by the agency if they comply
with relevant legal and regulatory
requirements. If FDA determines that
labeling for these drug products should
be revised to meet current standards, the
agency will advise ANDA applicants to
submit such labeling.
Dated: June 5, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–14000 Filed 6–12–09; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
16:47 Jun 12, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Improved Antibodies Against ErbB4/
Her4
National Institutes of Health
Description of Technology: ErbB4/
Her4 is a receptor tyrosine kinase that
regulates cell proliferation, cell
differentiation and cell survival. ErbB4
has been implicated in the pathology of
numerous cancers (e.g., breast cancer,
non-small cell lung carcinoma,
adenocarcinoma), as well as psychiatric
disorders (e.g., schizophrenia). As a
result, ErbB4 is an excellent target for
developing therapies against these
diseases. Unfortunately, the study of
ErbB4 has been slowed by the lack of
highly specific and functional
antibodies against the receptor.
In order to overcome the deficiencies
with current ErbB4 antibodies, NIH
inventors have generated three rabbit
monoclonal antibodies with improved
properties and versatility. Specifically,
the mAb-6, mAb-7 and mAb-10
hybridomas produce antibodies with a
high degree of specificity and affinity
for ErbB4. These antibodies recognize
specific epitopes on the intracellular
domains of ErbB4 without crossreaction against other proteins, and can
be used successfully in the
immunostaining of fixed tissue. Each
antibody recognizes both human and
mouse ErbB4, whereas only mAb-7 and
mAb-10 recognize rat ErbB4.
Applications:
• Basic research tool for the study of
ErbB4;
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION:
Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
ADDRESSES:
PO 00000
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]]>Agencies
[Federal Register Volume 74, Number 113 (Monday, June 15, 2009)]
[Notices]
[Pages 28255-28256]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14000]
[[Page 28255]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0254]
Determination That THORAZINE (Chlorpromazine Hydrochloride)
Injection and 18 Other Drug Products Were 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 the
19 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.
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 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors 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. 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 (the 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 Sec. 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 20-225 for IMDUR (isosorbide
mononitrate) Extended-Release Tablets in the Federal Register of
February 11, 2009 (74 FR 6896) and NDA 11-556 for ANTURANE
(sulfinpyrazone) Tablets and Capsules, NDA 15-500 for TOLINASE
(tolazamide) Tablets, NDA 18-285 for VISKEN (pindolol) Tablets, NDA 20-
137 for DEMADEX (torsemide) Injection, and NDA 20-154 for VIDEX
(didanosine) Chewable Tablets in the Federal Register of May 19, 2009
(74 FR 23407)).
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 9-149 THORAZINE GlaxoSmithKline, 2301
(chlorpromazine Renaissance Blvd.,
hydrochloride (HCI)) King of Prussia, PA
Injection, 25 19406
milligrams (mg)/
milliliter (mL)
------------------------------------------------------------------------
NDA 9-149 THORAZINE Do.
(chlorpromazine HCl)
Oral Concentrate, 30
mg/mL and 100 mg/mL
------------------------------------------------------------------------
NDA 9-149 THORAZINE Do.
(chlorpromazine HCl)
Oral Syrup, 10 mg/5 mL
------------------------------------------------------------------------
NDA 9-149 THORAZINE Do.
(chlorpromazine)
Suppositories, 25 mg
and 100 mg
------------------------------------------------------------------------
NDA 11-552 STELAZINE Do.
(trifluoperazine HCl)
Tablets, Equivalent to
(EQ) 1 mg base, EQ 2
mg base, EQ 5 mg base,
and EQ 10 mg base
------------------------------------------------------------------------
NDA 11-556 ANTURANE Novartis
(sulfinpyrazone) Pharmaceuticals
Tablet, 100 mg Corp., One Health
Plaza, East Hanover,
NJ 07963
------------------------------------------------------------------------
NDA 11-556 ANTURANE Do.
(sulfinpyrazone)
Capsule, 200 mg
------------------------------------------------------------------------
NDA 12-940 ISORDIL (isosorbide Biovail
dinitrate) Sublingual Pharmaceuticals,
Tablets, 2.5 mg, 5 mg, Inc., 700 Route 202-
and 10 mg 206 North,
Bridgewater, NJ 08807-
0980
------------------------------------------------------------------------
NDA 15-500 TOLINASE (tolazamide) Pfifzer, Inc., 235
Tablets, 100 mg, 250 East 42d St., New
mg, and 500 mg York, NY 10017
------------------------------------------------------------------------
[[Page 28256]]
NDA 18-154 LONITEN (minoxidil) Pharmacia & Upjohn
Tablets, 2.5 mg and 10 Co., c/o Pfizer, Inc.
mg
------------------------------------------------------------------------
NDA 18-285 VISKEN (pindolol) Novartis
Tablets, 5 mg and 10 Pharmaceuticals Corp.
mg
------------------------------------------------------------------------
NDA 18-445 DOLOBID (diflunisal) Merck & Co., Inc.,
Tablets, 250 mg and Sunneytown Pike, P.O.
500 mg Box 4, BLA-20, West
Point, PA 19486
------------------------------------------------------------------------
NDA 19-661 CYTOVENE IV Roche Laboratories,
(ganciclovir sodium) Inc., 340 Kingsland
Injection, EQ 500 mg St., Nutley, NJ 07110-
base/vial 1199
------------------------------------------------------------------------
NDA 20-027 CARDIZEM (diltiazem Biovail
HCl) Injection, 5 mg/ Pharmaecuticals, Inc.
mL and 25 mg/vial
------------------------------------------------------------------------
NDA 20-137 DEMADEX (torsemide) Roche Laboratories,
Injection, 20 mg/2 mL Inc.
(10 mg/mL) and 50 mg/5
mL (10 mg/mL)
------------------------------------------------------------------------
NDA 20-154 VIDEX (didanosine) Bristol-Myers Squibb
Chewable Tablets, 25 Co., P.O. Box 5100,
mg, 50 mg, 100 mg, 150 Wallingford, CT 06492-
mg, and 200 mg 7660
------------------------------------------------------------------------
NDA 20-225 IMDUR (isosorbide Schering Corp., 2000
mononitrate) Extended- Galloping Hill Rd.,
Release Tablets, 30 Kenilworth, NJ 07033
mg, 60 mg, and 120 mg
------------------------------------------------------------------------
NDA 21-238 KYTRIL (granisetron Roche Laboratories,
HCl) Oral Solution, EQ Inc.
2 mg base/10 mL
------------------------------------------------------------------------
NDA 21-301 LEVOXYL (levothyroxine King Pharmaceuticals,
sodium) Tablet, 0.3 mg Inc., 501 Fifth St.,
Bristol, TN 37620
------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs that refer to these products may also be
approved by the agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the agency will
advise ANDA applicants to submit such labeling.
Dated: June 5, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-14000 Filed 6-12-09; 8:45 am]
BILLING CODE 4160-01-S
