[Federal Register Volume 75, Number 47 (Thursday, March 11, 2010)]
[Notices]
[Pages 11549-11551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5275]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0109]


Determination That PRO-BANTHINE (Propantheline Bromide) Tablets 
and 14 Other Drug Products Were Not Withdrawn From Sale for Reasons of 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the 15 drug products listed in this document were not withdrawn from 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).

[[Page 11550]]

    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 
applicant, FDA withdrew approval of NDA 12-097 for KENALOG IN ORABASE 
(triamcinolone acetonide) Dental Paste in the Federal Register of 
February 11, 2009 (74 FR 6896).)

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 8-732                PRO-BANTHINE             Shire Pharmaceuticals,
                          (propantheline           Inc.,725 Chesterbrook
                          bromide) Tablets, 7.5    Blvd., Wayne, PA
                          milligrams (mg) and 15   19087)
                          mg
------------------------------------------------------------------------
NDA 12-097               KENALOG IN ORABASE       Apothecon, Inc., c/o
                          (triamcinolone           Bristol-Myers Squibb,
                          acetonide) Dental        P.O. Box 4500,
                          Paste, 0.1%              Princeton, NJ 08543-
                                                   4500
------------------------------------------------------------------------
NDA 12-141               CYTOXAN                  Baxter Healthcare
                          (cyclophosphamide)       Corp., 1620 Waukegan
                          Tablets, 25 mg and 50    Rd. MPGR-AL, McGaw
                          mg                       Park, IL 60085
------------------------------------------------------------------------
NDA 17-498               MICRONASE (glyburide)    Pharmacia and Upjohn
                          Tablets, 1.25 mg, 2.5    Co., 7171 Portage
                          mg, and 5 mg             Rd., Kalamazoo, MI
                                                   49001
------------------------------------------------------------------------
NDA 17-924               TAGAMET (cimetidine      GlaxoSmithKline, 5
                          HCl) Oral Solution,      Moore Dr., P.O. Box
                          Equivalent to (EQ) 300   13398, Research
                          mg base/5 mL             Triangle Park, NC
                                                   27709-3398
------------------------------------------------------------------------
NDA 18-207               DESYREL (trazodone HCl)  Apothecon, Inc.
                          Tablets, 50 mg, 100
                          mg, 150 mg, and 300 mg
------------------------------------------------------------------------
NDA 19-425               TRANDATE (labetalol      Prometheus
                          HCl) Injection, 5 mg/    Laboratories, Inc.,
                          mL                       9410 Carroll Park
                                                   Dr., San Diego, CA
                                                   92121
------------------------------------------------------------------------
NDA 20-101               PROZAC (fluoxetine HCl)  Eli Lilly and Co.,
                          Oral Solution, EQ 20     Lilly Corporate
                          mg base/5 mL             Center, Indianapolis,
                                                   IN 46285
------------------------------------------------------------------------
NDA 20-286               MONOPRIL-HCT             Bristol-Myers Squibb
                          (fosinopril sodium;      Co., P.O. Box 4000,
                          hydrochlorothiazide)     Princeton, NJ 08543-
                          Tablets, 10 mg/12.5      4000
                          mg, 20 mg/12.5 mg
------------------------------------------------------------------------
NDA 20-664               DOSTINEX (cabergoline)   Pharmacia and Upjohn
                          Tablet, 0.5 mg           Co.
------------------------------------------------------------------------
NDA 20-683               ALESSE (ethinyl          Wyeth Pharmaceuticals
                          estradiol;               Inc., P.O. Box 8299,
                          levonorgestrel)          Philadelphia, PA
                          Tablets (21 Tablets      19101-8299
                          and 28 Tablets), 0.02
                          mg; 0.1 mg
------------------------------------------------------------------------
NDA 20-801               PEPCID AC (famotidine)   Merck Research
                          Chewable Tablet, 10 mg   Laboratories,
                                                   Sumneytown Pike BLA
                                                   20, P.O. Box 4, West
                                                   Point, PA 19486-0004
------------------------------------------------------------------------
NDA 20-860               LEVLITE (ethinyl         Bayer Healthcare
                          estradiol;               Pharmaceuticals,
                          levonorgestrel)          Inc., 340
                          Tablets (21 Tablets      Changebridge Rd.,
                          and 28 Tablets), 0.02    P.O. Box 1000,
                          mg; 0.1 mg               Montville, NJ 07045-
                                                   1000
------------------------------------------------------------------------
NDA 21-455               BONIVA (ibandronate      Hoffmann LaRoche,
                          sodium) Tablet, EQ 2.5   Inc., 340 Kingsland
                          mg base                  St., Bldg. 719/4,
                                                   Nutley, NJ 07110-1199
------------------------------------------------------------------------
NDA 50-517               MEFOXIN (cefoxitin       Merck and Co., Inc.,
                          sodium) Injection, EQ    Sumneytown Pike BLA
                          1 gram (g) base/vial     20, P.O. Box 4, West
                          and EQ 2 g base/vial     Point, PA 19486-0004
------------------------------------------------------------------------

    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.


[[Page 11551]]


    Dated: March 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5275 Filed 3-10-10; 8:45 am]
BILLING CODE 4160-01-S