[Federal Register Volume 59, Number 61 (Wednesday, March 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7501]


[[Page Unknown]]

[Federal Register: March 30, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94N-0106]

 

Akorn, Inc., et al.; Withdrawal of Approval of 18 Abbreviated 
Antibiotic Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 18 abbreviated antibiotic applications (AADA's). The holders of the 
AADA's notified the agency in writing that the drug products were no 
longer marketed and requested that the approval of the applications be 
withdrawn.

EFFECTIVE DATE:  April 29, 1994.

FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug 
Evaluation and Research (HFD-360), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1038.

SUPPLEMENTARY INFORMATION: The holders of the AADA's listed in the 
table in this document have informed FDA that these drug products are 
no longer marketed and have requested that FDA withdraw approval of the 
applications. The applicants have also, by their request, waived their 
opportunity for a hearing.

------------------------------------------------------------------------
AADA No.                Drug                         Applicant          
------------------------------------------------------------------------
60-198     Sterile Penicillin G Procaine   Akorn, Inc., P.O. Box 1220,  
            Suspension, U.S.P..             Decatur, IL 62525.          
60-209     Ampicillin for Oral             Wyeth-Ayerst Laboratories,   
            Suspension, U.S.P..             P.O. Box 8299, Philadelphia,
                                            PA 19101-8299.              
60-362     Pencillin G Potassium for       Apothecon, P.O. Box 4500,    
            Injection, U.S.P..              Princeton, NJ 08543-4500.   
60-363     Penicillin G Sodium for         Do.                          
            Injection, U.S.P..                                          
60-520     Neomycin Sulfate Tablets,       The Upjohn Co., 7000 Portage 
            U.S.P..                         Rd., Kalamazoo, MI 49001-   
                                            0199.                       
61-048     Neomycin and Polymyxin B        Do.                          
            Sulfates and Bacitracin                                     
            Ophthalmic Ointment, U.S.P.                                 
61-140     Novobiocin Calcium, U.S.P.,     Do.                          
            (bulk).                                                     
61-238     Bacitracin (nonsterile bulk)..  Apothekernes Laboratorium,   
                                            A.S.,c/o A. L. Laboratories,
                                            Inc., One Executive Dr.,    
                                            P.O. Box 1399, Ft. Lee, NJ  
                                            07024.                      
61-443     Tetracycline Hydrochloride      Solvay Pharmaceuticals, 901  
            Capsules.                       Sawyer Rd., Marietta, GA    
                                            30062.                      
62-139     Sterile Minocycline             Lederle Laboratories, 401    
            Hydrochloride, U.S.P., 100      North Middletown Rd., Pearl 
            milligrams (mg)/vial.           River, NY 10965-1299.       
62-322     Erythromycin Stearate Tablets,  Warner-Chilcott Laboratories,
            U.S.P..                         201 Tabor Rd., Morris       
                                            Plains, NJ 07950.           
62-437     Chloramphenicol Ophthalmic      Pharmafair, Inc., 110 Kennedy
            Solution, U.S.P., 0.5%.         Dr., Hauppauge, NY 11788.   
62-439     Chloramphenicol Ophthalmic      Do.                          
            Ointment, U.S.P., 1%.                                       
62-453     Bacitracin Ophthalmic           Do.                          
            Ointment, U.S.P..                                           
62-546     Erythromycin Capsules, U.S.P.,  Parke-Davis, 2800 Plymouth   
            250 mg.                         Rd., Ann Arbor, MI 48105.   
62-562     Amikacin Sulfate Injection,     Apothecon.                   
            U.S.P..                                                     
62-564     Kanamycin Sulfate Injection,    Do.                          
            U.S.P..                                                     
62-978     Cloxacillin Sodium Oral         Novopharm Ltd., c/o Therese  
            Solution, U.S.P., 125 mg/5      M. Ast, 176 East 17th St.,  
            milliliters.                    New York, NY 10021.         
------------------------------------------------------------------------

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the 
Director, Center for Drug Evaluation and Research (21 CFR 5.82), 
approval of the AADA's listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective April 29, 1994.

    Dated: March 15, 1994.
 Murray M. Lumpkin,
 Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-7501 Filed 3-29-94; 8:45 am]
BILLING CODE 4160-01-F