Document ID: FDA-2009-N-0254-0001
Agency: fda
Document Type: Notice
Title: Determination: THORAZINE Injection and 18 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Posted Date: 2009-06-15T04:00Z

[Federal Register: June 15, 2009 (Volume 74, Number 113)]
[Notices]               
[Page 28255-28256]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jn09-66]                         

[[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Injection and 18 Other Drug Products Were Not Withdrawn From Sale for 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.

-----------------------------------------------------------------------

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19 drug products listed in this document were not withdrawn from sale 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