[Federal Register Volume 68, Number 151 (Wednesday, August 6, 2003)]
[Notices]
[Pages 46645-46646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19946]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0336]


Determination That Benztropine Mesylate 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Drug Products Were Not Withdrawn From Sale for Reasons of Safety or 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.

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SUMMARY: 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10 drug products listed in this document were not withdrawn from sale 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. These are drug products with 
approved new drug applications (NDAs) to which one or more approved 
abbreviated new drug applications (ANDAs) refer. This determination 
means that the approval status of the ANDAs is unaffected by the 
withdrawal from sale of the reference product.

FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (the 1984 
amendments) (Public Law 98-417), 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 under a new drug 
application (NDA). Sponsors of ANDAs do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
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 Under FDA regulations, drugs are withdrawn from the list if the 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 (Sec.  314.162 (21 CFR 314.162)).
    If a listed drug is withdrawn from sale and there are approved 
ANDAs that refer to that drug, under Sec.  314.161(a)(2) (21 CFR 
314.161(a)(2)), the agency must determine whether the listed drug was 
withdrawn from sale for reasons of safety or effectiveness. Section 
314.161(d) provides that if FDA determines that the listed drug was 
removed from sale for safety or effectiveness reasons, the agency will 
initiate proceedings that could result in the withdrawal of approval of 
the ANDAs that refer to the listed drug.
    The holders of the applications listed in the table in this 
document have informed FDA that the drug products have been withdrawn 
from sale. The drug products in the table are subjects of approved NDAs 
to which one or more approved ANDAs refer.

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        NDA No.                    Drug                  Applicant
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9-193                    Cogentin (benztropine    Merck & Co., Inc., BLA-
                          mesylate) Tablets,       20, P.O. Box 4, West
                          0.5, 1, and 2            Point, GA 19486-0004.
                          milligrams (mg).
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[[Page 46646]]

 
11-835                   HydroDiuril (hydro-      Do.
                          chlorothiazide)
                          Tablets, 25, 50, and
                          100 mg.
------------------------------------------------------------------------
12-383                   Colbenemid (colchicine;  Do.
                          probenecid) Tablets,
                          0.5 mg; 500 mg.
------------------------------------------------------------------------
15-921                   Haldol (haloperidol)     Ortho-McNeil
                          Tablets, 0.5, 1, 2, 5,   Pharmaceutical, Inc.
                          10, and 20 mg.           1000 Route 202, P.O.
                                                   Box 600, Raritan, NJ
                                                   08869-0600.
------------------------------------------------------------------------
17-657                   Cephulac (lactulose)     Aventis
                          Solution, 10 grams/15    Pharmaceuticals, 300
                          mL.                      Somerset Corporate
                                                   Blvd., Bridgewater,
                                                   NJ 08807-2854.
------------------------------------------------------------------------
17-814                   Indocin (indomethacin)   Merck & Co., Inc.
                          Suppositories, 50 mg.
------------------------------------------------------------------------
17-851                   Lioresal (baclofen)      Novartis
                          Tablets, 10 and 20 mg.   Pharmaceuticals
                                                   Corp., One Health
                                                   Plaza, East Hanover,
                                                   NJ 07936.
------------------------------------------------------------------------
18-654                   Versed (midazolam        Roche Pharmaceuticals,
                          hydrochloride (HCl))     Division of Hoffmann-
                          Injection, 1 mg/mL and   LaRoche, Inc., 340
                          5 mg/mL.                 Kingsland St.,
                                                   Nutley, NJ 07110.
------------------------------------------------------------------------
20-095                   Zantac (ranitidine HCl)  GlaxoSmithKline, P.O.
                          Geldose Capsules, 150    Box 13398, Five Moore
                          and 300 mg.              Dr., Research
                                                   Triangle Park, NC
                                                   27709.
------------------------------------------------------------------------
20-942                   Versed (midazolam HCl)   Roche Pharmaceuticals.
                          Syrup, 2 mg/mL.
------------------------------------------------------------------------

    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. Approved 
ANDAs that refer to the NDAs listed in this document are unaffected by 
the withdrawal of the products subject to those NDAs, and 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.

    Dated: July 28, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-19946 Filed 8-5-03; 8:45 am]
BILLING CODE 4160-01-S