[Federal Register Volume 73, Number 191 (Wednesday, October 1, 2008)]
[Notices]
[Pages 57109-57111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23035]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0506]


Determination That ATROVENT (Ipatropium Bromide) Inhalation 
Solution and 10 Other Drug Products Were Not Withdrawn From Sale for 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 
11 drug products listed in this document were not withdrawn from sale 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

[[Page 57110]]

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 Sec.  10.25(a) and Sec.  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 20-228 for ATROVENT 
(ipratropium bromide) Inhalation Solution in the Federal Register of 
November 7, 2007 (72 FR 62858).)

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 20-228               ATROVENT (ipratropium    Boehringer Ingelheim
                          bromide) Inhalation      Pharmaceuticals,
                          Solution, 0.02%          Inc., 900 Ridgebury
                                                   Rd., P.O. Box 368,
                                                   Ridgefield, CT 06877-
                                                   0368
------------------------------------------------------------------------
NDA 20-306               Fludeoxyglucose F-18 (4- Downstate Clinical PET
                          40 millicuries (mCi)/    Center, Methodist
                          milliliter (mL) and 4-   Medical Center, 112
                          90 mCi/mL) Injection     Crescent Ave.,
                                                   Peoria, IL 61606
------------------------------------------------------------------------
NDA 20-333               AGRYLIN (anagrelide      Shire US Inc., 725
                          hydrochloride (HCl))     Chesterbrook Blvd.,
                          Capsules, equivalent     Wayne, PA 19087-5637
                          to (EQ) 1 milligram
                          (mg) base
------------------------------------------------------------------------
NDA 20-377               CORDARONE (amiodarone    Wyeth Pharmaceuticals,
                          HCl) Injection, 50 mg/   P.O. Box 8299,
                          mL                       Philadelphia, PA
                                                   19101-8299
------------------------------------------------------------------------
NDA 20-974               PROZAC (fluoxetine HCl)  Eli Lilly and Co.,
                          Tablets, EQ 10 mg base   Lilly Corporate
                                                   Center, Indianapolis,
                                                   IN 46285
------------------------------------------------------------------------
NDA 50-417               NEOSPORIN (bacitracin    Monarch
                          zinc; neomycin           Pharmaceuticals,
                          sulfate; polymyxin B     Inc., c/o King
                          sulfate) Ophthalmic      Pharmaceuticals,
                          Ointment, 400 units/     Inc., 501 Fifth St.,
                          gram (g); EQ 3.5 mg      Bristol, TN 37620
                          base/g; 10,000 units/g
------------------------------------------------------------------------
NDA 50-461               ANCEF (cefazolin         GlaxoSmithKline, 2301
                          sodium) Injection, 250   Renaissance Blvd.,
                          mg/vial, 500 mg/vial,    King of Prussia, PA
                          and 5 g/vial             19406
------------------------------------------------------------------------
NDA 50-521               CECLOR (cefaclor)        Eli Lilly and Co.
                          Capsules, EQ 250 mg
                          and 500 mg base
------------------------------------------------------------------------
NDA 50-522               CECLOR (cefaclor) Oral   Do.
                          Suspension, EQ 125 mg
                          base/5 mL and EQ 250
                          mg base/5 mL
------------------------------------------------------------------------
NDA 50-527               DURICEF (cefadroxil)     Warner Chilcott, Inc.,
                          Oral Suspension, EQ      Rockaway 80 Corporate
                          125 mg base/5 mL         Center, 100
                                                   Enterprise Dr., suite
                                                   280, Rockaway, NJ
                                                   07866
------------------------------------------------------------------------
ANDA 61-229              POLYSPORIN (bacitracin   Monarch
                          zinc; polymyxin B        Pharmaceuticals, Inc.
                          sulfate) Ophthalmic
                          Ointment, 500 units/g;
                          10,000 units/g
------------------------------------------------------------------------

    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

[[Page 57111]]

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: September 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23035 Filed 9-30-08; 8:45 am]
BILLING CODE 4160-01-S