[Federal Register Volume 59, Number 41 (Wednesday, March 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4660]


[[Page Unknown]]

[Federal Register: March 2, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0044]

 

Riker Laboratories, Inc., et al.; Withdrawal of Approval of 91 
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 91 new drug applications (NDA's). The holders of the NDA's notified 
the agency in writing that the drug products were no longer being 
marketed under the NDA's and requested that the approval of the 
applications be withdrawn.

EFFECTIVE DATE: April 1, 1994.

FOR FURTHER INFORMATION CONTACT: Nancy Maizel, Center for Drug 
Evaluation and Research (HFD-53), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-4320.

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

------------------------------------------------------------------------
NDA No.                                                                 
                     Drug                           Applicant           
------------------------------------------------------------------------
0-607..  Ophthalmic Isophrin Solution.  Riker Laboratories, Inc., 3M    
                                         Pharmaceuticals, 270-3A 3M     
                                         Center, St. Paul, MN 55144.    
2-139..  Menadione and Proklo Tablets.  Lilly Research Laboratories,    
                                         Division of Eli Lilly and Co., 
                                         Lilly Corporate Center,        
                                         Indianapolis, IN 46285.        
3-895..  Heparin Sodium Injection.....  Lederle Laboratories, Division  
                                         of American Cyanamid Co., Pearl
                                         River, NY 10965.               
4-203..  Zylate Solution and Emulsion.  The Upjohn Co., U.S.            
                                         Pharmaceutical Regulatory      
                                         Affairs, 7000 Portage Rd.,     
                                         Kalamazoo, MI 49001-0199.      
5-725..  Kappadione Injection.........  Lilly Research Laboratories.    
5-969..  Racemic Desoxyephedrine HCl    High Chemical Co., 1760 North   
          Tablets.                       Howard St., Philadelphia, PA   
                                         19122.                         
6-087..  Topocide Lotion..............  Lilly Research Laboratories.    
6-303..  Thephorin Tablets, Lotion and  Hoffmann-La Roche Inc., 340     
          Ointment.                      Kingsland St., Nutley, NJ 07110-
                                         1199.                          
6-317..  Neotrizine Tablets and         Lilly Research Laboratories.    
          Suspension, Co-Diazine                                        
          Suspension, Sulfonamides                                      
          Duplex Suspension, and                                        
          Sulfonamides Duplex Savoret                                   
          Tablets.                                                      
6-441..  Camoquin HCl Tablets.........  Parke-Davis Pharmaceutical      
                                         Research, Division of Warner-  
                                         Lambert Co., 2800 Plymouth Rd.,
                                         Ann Arbor, MI 48105.           
6-798..  Berubigen Injection..........  The Upjohn Co.                  
6-946..  Aminosalicylic Acid and        Merck Research Laboratories,    
          Sodium Aminosalicylate         Merck & Co. Inc., West Point,  
          Powders.                       PA 19486.                      
7-037..  Berubigen Capsules...........  The Upjohn Co.                  
7-245..  Aerolone Solution............  Lilly Research Laboratories.    
7-384..  Cologel Liquid...............  Do.                             
7-448..  Aminosalicylic Acid Tablets..  Do.                             
8-059..  Thiomerin and Thiomerin        Wyeth-Ayerst Laboratories Inc., 
          Sodium Injections.             P.O. Box 8299, Philadelphia, PA
                                         19101.                         
8-301..  Sunstick Ointment............  S.C. Johnson Wax, S.C. Johnson &
                                         Son Inc., 1525 Howe St.,       
                                         Racine, WI 53403-5011.         
8-576..  Teebaconin Tablets...........  Palisades Pharmaceuticals Inc., 
                                         219 County Rd., Tenafly, NJ    
                                         07670.                         
8-814..  Unitensen Injection..........  Wallace Laboratories, Division  
                                         of Carter-Wallace Inc., 301B   
                                         College Rd. East, Princeton, NJ
                                         08540.                         
8-869..  Dicurin Procaine Injection...  Lilly Research Laboratories.    
8-915..  Clistin Tablets..............  R.W. Johnson Pharmaceutical     
                                         Research Institute, Welsh and  
                                         McKean Rds., Spring House, PA  
                                         19477-0776.                    
8-973..  Primaquine Tablets...........  Parke-Davis Pharmaceutical      
                                         Research.                      
8-993..  Marezine Tablets.............  Burroughs Wellcome Co., 3030    
                                         Cornwallis Rd., Research       
                                         Triangle Park, NC 27709.       
9-217..  Unitensen Tablets............  Wallace Laboratories.           
9-276..  Rauwolfia Serpentina and       JMI-Canton Pharmaceuticals,     
          Hiwolfia Tablets.              Inc., 119 Schroyer Ave. SW.,   
                                         Canton, OH 44702.              
9-312..  Romilar Syrup................  Hoffmann-La Roche Inc.          
9-344..  Histalog Injection...........  Lilly Research Laboratories.    
9-631..  Reserpine and Hiserpia         JMI-Canton Pharmaceuticals, Inc.
          Tablets.                                                      
9-645..  Reserpine and Serpivite        Vitarine Pharmaceuticals Inc.,  
          Tablets.                       227-15 North Conduit Ave.,     
                                         Springfield Gardens, NY 11413. 
9-789..  Mylaxen Injection............  Wallace Laboratories.           
9-980..  Camoprim Tablets.............  Parke-Davis Pharmaceutical      
                                         Research.                      
10-289.  Betadine Ointment............  The Purdue Frederick Co., 100   
                                         Connecticut Ave., Norwalk, CT  
                                         06850-3590.                    
10-290.  Betadine Mouthwash...........  Do.                             
10-573.  Sodium Versenate Injection...  Riker Laboratories, Inc.        
10-586.  Doxan Tablets................  Hoechst-Roussel Pharmaceuticals 
                                         Inc., Route 202-206 North,     
                                         Somerville, NJ 08876.          
10-895.  Norlutin Tablets.............  Parke-Davis Pharmaceutical      
                                         Research.                      
11-047.  Cardrase Tablets.............  The Upjohn Co.                  
11-267.  Halodrin Tablets.............  Do.                             
11-294.  Trilafon Syrup...............  Schering Corp., Galloping Hill  
                                         Rd., Kenilworth, NJ 07033.     
11-361.  Trilafon Tablets.............  Do.                             
11-429.  Betadine Aerosol Spray.......  The Purdue Frederick Co.        
11-491.  Vesprin Suspension and         Apothecon, Bristol-Myers Squibb 
          Emulsion.                      Co., P.O. Box 4500, Princeton, 
                                         NJ 08543-4500.                 
11-914.  Virac Surgical and Virac Rex   Sherwood Medical, 1915 Olive    
          Solutions.                     St., St. Louis, MO 63103-1642. 
11-945.  Hispril Capsules.............  SmithKline Beecham              
                                         Pharmaceuticals, Four Falls    
                                         Corporate Center, Route 23 and 
                                         Woodmont Ave., P.O. Box 1510,  
                                         King of Prussia, PA 19406.     
12-033.  Sevinol Tablets..............  Schering Corp.                  
12-126.  ULO (chlophedianol             Riker Laboratories Inc.         
          hydrochloride) Syrup.                                         
12-155.  Rela Tablets.................  Schering Corp.                  
12-273.  Betadine Surgical Scrub        The Purdue Frederick Co.        
          Liquid.                                                       
12-307.  SunDare Clear Lotion.........  S.C. Johnson Wax.               
12-728.  Ortho-Novum 10 milligrams      R.W. Johnson Pharmaceutical     
          (mg), Ortho-Novum 2 mg-20,     Research Institute.            
          Ortho-Novum 2 mg-21, and                                      
          Ortho-Novum 1/50-20 Tablets                                   
          (those portions of NDA only).                                 
12-751.  Head and Shoulders Shampoo...  The Procter & Gamble Co., Sharon
                                         Woods Technical Center, 11511  
                                         Reed Hartman Hwy., Cincinnati, 
                                         OH 45241-9974.                 
12-936.  Drolban Injection............  Lilly Research Laboratories.    
13-141.  Sonilyn Tablets..............  Wallace Laboratories.           
13-376.  Propoquin Dihydrochloride      Parke-Davis Pharmaceutical      
          Injection.                     Research.                      
13-554.  Norlestrin 2.5-mg Tablets....  Do.                             
14-360.  Head and Shoulders Shampoo...  The Procter & Gamble Co.        
14-968.  Dristan Sustained Action       Whitehall Laboratories, 685     
          Capsules.                      Third Ave., New York, NY 10017-
                                         4076.                          
16-242.  Norlestrin Tablets...........  Parke-Davis Pharmaceutical      
                                         Research.                      
16-393.  Head and Shoulders Shampoo...  The Procter & Gamble Co.        
16-605.  Head and Shoulders Lotion      Do.                             
          Shampoo.                                                      
16-723.  Norlestrin 28 1/50 Tablets...  Parke-Davis Pharmaceutical      
                                         Research.                      
16-735.  Surgidine Solution...........  Wallace Laboratories.           
16-766.  Norlestrin FE 1/50 Tablets...  Parke-Davis Pharmaceutical      
                                         Research.                      
16-813.  Vapo-Iso Inhalant............  Fisons Pharmaceuticals, Fisons  
                                         Corp., Jefferson Rd., P.O. Box 
                                         1710, Rochester, NY 14603.     
17-033.  Heparin Sodium and Sodium      Lyphomed Inc., 2045 North       
          Heparin Injections.            Cornell Ave., Melrose Park, IL 
                                         60160-1002.                    
17-079.  Haldol Solutab Tablets.......  R.W. Johnson Pharmaceutical     
                                         Research Institute.            
17-346.  Heparin Sodium and Heparin     Parke-Davis Pharmaceutical      
          Lock Flush Injections.         Research.                      
17-366.  Mucomyst with Isoproterenol    Bristol-Myers Squibb Co.,       
          Solution.                      Bristol-Myers U.S.             
                                         Pharmaceutical Group, 2400 West
                                         Lloyd Expressway, Evansville,  
                                         IN 47721-0001.                 
17-374.  Dormate Tablets..............  Wallace Laboratories.           
17-415.  Centrax Tablets and Verstran   Parke-Davis Pharmaceutical      
          Capsules.                      Research.                      
17-485.  Vosol Otic Solution..........  Wallace Laboratories.           
17-718.  Heprinar Injection...........  Armour Pharmaceutical Co., A    
                                         Company of Rorer Group Inc.,   
                                         500 Virginia Dr., Fort         
                                         Washington, PA 19034.          
18-232.  Somophyllin Enema............  Fisons Pharmaceuticals.         
18-296.  Tymtran Injection............  Adria Laboratories, P.O. Box    
                                         16529, Columbus, OH 43216-6529.
18-497.  Sodium Chloride 0.45%          Baxter Healthcare Corp.,        
          Solution.                      Parenterals Division, Route 120
                                         and Wilson Rd., Round Lake, IL 
                                         60073.                         
18-522.  Glycine 1.5% Solution........  Do.                             
19-130.  Heparin Sodium 1,000 Units in  Kendall McGaw Laboratories Inc.,
          Dextrose 5%, Heparin Sodium    P.O. Box 25080, Santa Ana, CA  
          5,000 Units in Dextrose 5%,    92799-5080.                    
          and Heparin Sodium 2,000                                      
          Units in Dextrose 5%                                          
          Injections.                                                   
19-326.  Synovalyte Solution in         Baxter Healthcare Corp.         
          Plastic Container.                                            
19-412.  Head and Shoulders             The Proctor and Gamble Co.      
          Conditioner Lotion.                                           
19-490.  Curity Surgical Scrub Brush-   Becton Dickinson AcuteCare, 9450
          Sponge.                        South State St., Sandy, UT     
                                         84070-3234.                    
50-046.  Veracillin Capsules..........  Wyeth-Ayerst Laboratories.      
50-056.  Principen '250' and Principen  Apothecon.                      
          '500' Capsules.                                               
50-183.  Chloromycetin Cream..........  Parke-Davis Pharmaceutical      
                                         Research.                      
50-203.  Chloromyxin Ophthalmic         Do.                             
          Ointment.                                                     
50-289.  Coly-Mycin S Ophthalmic Drops  Do.                             
50-374.  Neo-Cortef Lotion............  The Upjohn Co.                  
50-450.  Mutamycin Powder for           Bristol-Myers Squibb Co.        
          Injection.                                                    
50-488.  Principen with Probenecid      Apothecon.                      
          Capsules.                                                     
50-495.  Amikin Injection.............  Do.                             
------------------------------------------------------------------------

    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 of the Center for Drug Evaluation and Research (21 CFR 5.82), 
approval of the NDA's listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective April 1, 1994.

    Dated: February 3, 1994.
Gerald F. Meyer,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-4660 Filed 3-1-94; 8:45 am]
BILLING CODE 4160-01-P