[Federal Register Volume 60, Number 238 (Tuesday, December 12, 1995)]
[Notices]
[Pages 63720-63721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30122]



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[[Page 63721]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95N-0346]


Akorn, Inc., et al.; Withdrawal of Approval of NADA's

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of five new animal drug applications (NADA's). Three NADA's are held by 
Akorn, Inc., and one each is held by Parke-Davis, Division of Warner-
Lambert Co., and Veterinary Research and Development, Inc. The firms 
notified the agency in writing that the animal drug products were no 
longer marketed and requested that approval of the applications be 
withdrawn. In a final rule published elsewhere in this issue of the 
Federal Register, FDA is amending the regulations by removing the 
entries which reflect approval of the NADA's.

EFFECTIVE DATE: December 22, 1995.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0159.

SUPPLEMENTARY INFORMATION: The sponsors of the applications listed in 
the table in this document have informed FDA that these animal drug 
products are no longer marketed and have requested that FDA withdraw 
approval of the applications.

                                                                        
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                                                       Sponsor name and 
            NADA No.                  Drug name             address     
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6-032..........................  Diphenylhydantoin    Parke-Davis,      
                                  sodium capsules.     Division of      
                                                       Warner-Lambert   
                                                       Co., 201 Tabor   
                                                       Rd., Morris      
                                                       Plains, NJ 07950 
12-444.........................  Sterile              Akorn, Inc., 100  
                                  prednisolone         Akorn Dr., Abita 
                                  suspension.          Springs, LA 70420
94-978.........................  Phenylbutazone        Do.              
                                  injection.                            
110-046........................  Dexamethasone         Do.              
                                  injection.                            
140-904........................  Copper disodium      Veterinary        
                                  edetate injection.   Research and     
                                                       Development,     
                                                       Inc., P.O. Box   
                                                       1299, Truckee, CA
                                                       95734            
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADA's 6-032, 12-444, 94-978, 110-046, and 140-904 and all 
supplements and amendments thereto is hereby withdrawn, effective 
December 22, 1995.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is removing 21 CFR 520.704, 522.514, and 522.1880, and 
amending 21 CFR 510.600(c), 522.540, and 522.1720 to reflect the 
withdrawal of approval of the above mentioned NADA's.

    Dated: December 4, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-30122 Filed 12-11-95; 8:45 am]
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