[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)]
[Notices]
[Pages 11106-11107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5060]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0051]


Solvay Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 
11 Abbreviated Antibiotic Applications and 11 Abbreviated New Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 11 abbreviated antibiotic applications (AADA's) and 11 abbreviated 
new drug applications (ANDA's). The holders of the applications 
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withdrawn.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: March 31, 1995.

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 applications 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.

                                                                                                                
[[Page 11107]]
------------------------------------------------------------------------
        AADA No.                   Drug                  Applicant      
------------------------------------------------------------------------
60-128..................  Ampicillin Trihydrate.  IBI, Giovanni         
                                                   Lorenzini S.p.A.,    
                                                   20139 Milano, Italy. 
60-130..................  Ampicillin............  Do.                   
61-659..................  Erythromycin Delayed-   Solvay                
                           Release Tablets,        Pharmaceuticals,     
                           U.S.P., 250             Inc., 901 Sawyer Rd.,
                           milligrams (mg).        Marietta, GA 30062.  
61-818..................  Cephalexin Monohydrate  IBI.                  
61-923..................  Amoxicillin Trihydrate  Do.                   
62-052..................  Nystatin Ointment,      Lemmon Co., 650       
                           U.S.P..                 Cathill Rd.,         
                                                   Sellersville, PA     
                                                   18960.               
62-430..................  Bacitracin Zinc and     Pharmafair, Inc., 110 
                           Polymyxin B Sulfate     Kennedy Dr.,         
                           Ophthalmic Ointment,    Hauppauge, NY 11788. 
                           U.S.P..                                      
62-449..................  Cephalothin Sodium....  IBI.                  
62-666..................  Cephalothin Sodium for  Fujisawa USA, Inc.,   
                           Injection, U.S.P., 1    Parkway North Center,
                           gram (g) and 2 g.       Three Parkway North, 
                                                   Deerfield, IL 60015- 
                                                   2548                 
62-710..................  Cephalothin Sodium....  IBI.                  
62-747..................  Clindamycin Phosphate   Fujusawa USA, Inc.    
                           Injection, U.S.P.,                           
                           150 mg/milliliters                           
                           (mL).                                        
------------------------------------------------------------------------


------------------------------------------------------------------------
        ANDA No.                   Drug                  Applicant      
------------------------------------------------------------------------
80-041..................  Trisulfapyrimidines     Solvay                
                           Oral Suspension,        Pharmaceuticals, Inc.
                           U.S.P., 0.5 g/5 mL.                          
80-921..................  Vitamin A Capsules,     Lemmon Co.            
                           U.S.P., 50,000 units.                        
83-993..................  Phendimetrazine         Solvay                
                           Tartrate Tablets,       Pharmaceuticals, Inc.
                           U.S.P., 35 mg.                               
84-435..................  Meprobamate Tablets,    Do.                   
                           U.S.P., 200 mg.                              
85-897..................  Phendimetrazine         Do.                   
                           Tartrate Capsules,                           
                           U.S.P., 35 mg.                               
87-074..................  Diatrizoate Meglumine   Mallinckrodt Medical, 
                           and Diatriozoate        Inc., P.O. Box 5840, 
                           Sodium Injectin,        St. Louis, MO 63134. 
                           U.S.P..                                      
87-113..................  Triamcinolone           Solvay                
                           Acetonide Cream,        Pharmaceuticals, Inc.
                           U.S.P. 0.1%.                                 
87-210..................  Reserpine, Hydralazine  Do.                   
                           Hydrochloride, and                           
                           Hydrochlorothiazide                          
                           Tablets, U.S.P., 0.1                         
                           mg/25 mg/15 mg.                              
87-833..................  Prednisone Tablets,      Roxane Laboratories, 
                           U.S.P., 25 mg.          Inc., P.O. Box 16532,
                                                   Columbus, OH 43216-  
                                                   6532                 
88-071..................  Dexamethasone Sodium    Pharmafair, Inc.      
                           Phosphate Ophthalmic                         
                           Ointment, U.S.P.,                            
                           0.05%.                                       
88-612..................  Phentermine             Lemmon Co.            
                           Hydrochloride                                
                           Capsules, U.S.P., 30                         
                           mg.                                          
------------------------------------------------------------------------

  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 applications listed above, and all amendments and 
supplements thereto, is hereby withdrawn, effective March 31, 1995.

    Dated: February 16, 1995.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-5060 Filed 2-28-95; 8:45 am]
BILLING CODE 4160-01-F