[Federal Register Volume 72, Number 172 (Thursday, September 6, 2007)]
[Notices]
[Pages 51232-51233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-17566]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0329]


Determination That MILTOWN (Meprobamate) Tablets and Five 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Drug Products Were Not Withdrawn From Sale for Reasons of Safety or 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the six drug products listed in this document were not withdrawn from 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 the drug products, and it 
will allow FDA to continue to approve ANDAs that refer to the products.

FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20855,301-594-2041.

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 (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 Under FDA regulations, drugs are withdrawn from the list if the 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 (21 CFR 314.162).

[[Page 51233]]

    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 or (2) whenever a listed drug is voluntarily 
withdrawn from sale, and ANDAs that refer to the listed drug have been 
approved. Section 314.161(d) provides that if FDA determines that a 
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.
    FDA has become aware that the drug products listed in the table in 
this document are no longer being marketed.

------------------------------------------------------------------------
   NDA No.                Drug                        Applicant
------------------------------------------------------------------------
9-698         MILTOWN (meprobamate)         Medpointe Pharmaceuticals,
               Tablets, 200 milligrams       265 Davidson Ave., Suite
               (mg) and 400 mg               300, Somerset, NJ 08873-
                                             4120
------------------------------------------------------------------------
17-481        VERMOX (mebendazole)          McNeil Consumer & Specialty
               Chewable Tablets, 100 mg      Pharmaceuticals, 7050 Camp
                                             Hill Rd., Fort Washington,
                                             PA 19034-2999
------------------------------------------------------------------------
18-226        BUMEX (bumetanide)            Roche Laboratories, Inc.,
               Injection, 0.25 mg/           340 Kingsland St., Nutley,
               milliliter                    NJ 07110-1199
------------------------------------------------------------------------
20-463        NASALCROM (cromolyn sodium)   Pfizer Consumer Healthcare,
               Spray, 5.2 mg/spray           201 Tabor Rd., Morris
                                             Plains, NJ 07950
------------------------------------------------------------------------
21-203        TRICOR (fenofibrate)          Abbott Laboratories, 200
               Tablets, 54 mg and 160 mg     Abbott Park Rd., D-89J45-2,
                                             Abbott Park, IL 60064-6133
------------------------------------------------------------------------
50-517        MEFOXIN (cefoxitin) for       Merck & Co., Inc.,
               Injection, 10 grams/vial      Sumneytown Pike, BLA-20,
                                             P.O. Box 4, West Point, PA
                                             19486
------------------------------------------------------------------------

    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 for the 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: August 29, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-17566 Filed 9-5-07; 8:45 am]
BILLING CODE 4160-01-S