[Federal Register Volume 74, Number 113 (Monday, June 15, 2009)]
[Notices]
[Pages 28255-28256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14000]
[[Page 28255]]
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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Injection and 18 Other Drug Products Were Not Withdrawn From Sale for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.
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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19 drug products listed in this document were not withdrawn from sale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)).
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Application No. Drug Applicant
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NDA 9-149 THORAZINE GlaxoSmithKline, 2301
(chlorpromazine Renaissance Blvd.,
hydrochloride (HCI)) King of Prussia, PA
Injection, 25 19406
milligrams (mg)/
milliliter (mL)
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NDA 9-149 THORAZINE Do.
(chlorpromazine HCl)
Oral Concentrate, 30
mg/mL and 100 mg/mL
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NDA 9-149 THORAZINE Do.
(chlorpromazine HCl)
Oral Syrup, 10 mg/5 mL
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NDA 9-149 THORAZINE Do.
(chlorpromazine)
Suppositories, 25 mg
and 100 mg
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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
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NDA 11-556 ANTURANE Novartis
(sulfinpyrazone) Pharmaceuticals
Tablet, 100 mg Corp., One Health
Plaza, East Hanover,
NJ 07963
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NDA 11-556 ANTURANE Do.
(sulfinpyrazone)
Capsule, 200 mg
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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
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NDA 15-500 TOLINASE (tolazamide) Pfifzer, Inc., 235
Tablets, 100 mg, 250 East 42d St., New
mg, and 500 mg York, NY 10017
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[[Page 28256]]
NDA 18-154 LONITEN (minoxidil) Pharmacia & Upjohn
Tablets, 2.5 mg and 10 Co., c/o Pfizer, Inc.
mg
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NDA 18-285 VISKEN (pindolol) Novartis
Tablets, 5 mg and 10 Pharmaceuticals Corp.
mg
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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
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NDA 19-661 CYTOVENE IV Roche Laboratories,
(ganciclovir sodium) Inc., 340 Kingsland
Injection, EQ 500 mg St., Nutley, NJ 07110-
base/vial 1199
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NDA 20-027 CARDIZEM (diltiazem Biovail
HCl) Injection, 5 mg/ Pharmaecuticals, Inc.
mL and 25 mg/vial
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NDA 20-137 DEMADEX (torsemide) Roche Laboratories,
Injection, 20 mg/2 mL Inc.
(10 mg/mL) and 50 mg/5
mL (10 mg/mL)
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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
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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
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NDA 21-238 KYTRIL (granisetron Roche Laboratories,
HCl) Oral Solution, EQ Inc.
2 mg base/10 mL
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NDA 21-301 LEVOXYL (levothyroxine King Pharmaceuticals,
sodium) Tablet, 0.3 mg Inc., 501 Fifth St.,
Bristol, TN 37620
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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