95-17236. Drug Export; Preservative-Free Intravenous Sodium EdecrinRegister (Ethacrynate Sodium) 50 Milligrams (mg) Ethacrynic Acid Equivalent/50 Milliliters (mL) in 60 mL Glass Bottle  

  • [Federal Register Volume 60, Number 134 (Thursday, July 13, 1995)]
    [Notices]
    [Pages 36151-36152]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-17236]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    [Docket No. 95N-0202]
    
    
    Drug Export; Preservative-Free Intravenous Sodium 
    Edecrin (Ethacrynate Sodium) 50 Milligrams (mg) Ethacrynic 
    Acid Equivalent/50 Milliliters (mL) in 60 mL Glass Bottle
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Notice.
    
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    SUMMARY: The Food and Drug Administration (FDA) is announcing that 
    Merck & Co. has filed an application requesting approval for the export 
    of the human drug Preservative-Free Intravenous Sodium 
    Edecrin (ethacrynate sodium) 50 mg ethacrynic acid 
    equivalent/50 mL in 60 mL glass bottle to Germany through the 
    Netherlands for further packaging and labeling.
    
    ADDRESSES: Relevant information on this application may be directed to 
    the Dockets Management Branch (HFA-305), Food and Drug Administration, 
    rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and to the contact 
    person identified below. Any future inquiries concerning the export of 
    human drugs under the Drug Export Amendments Act of 1986 should also be 
    directed to the contact person.
    
    FOR FURTHER INFORMATION CONTACT: James E. Hamilton, Center for Drug 
    Evaluation and Research (HFD-310), Food and Drug Administration, 7520 
    Standish Pl., Rockville, MD 20855, 301-594-3150.
    
    
    [[Page 36152]]
    
    SUPPLEMENTARY INFORMATION: The drug export provisions in section 802 of 
    the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 382) 
    provide that FDA may approve applications for the export of drugs that 
    are not currently approved in the United States. Section 802(b)(3)(B) 
    of the act sets forth the requirements that must be met in an 
    application for approval. Section 802(b)(3)(C) of the act requires that 
    the agency review the application within 30 days of its filing to 
    determine whether the requirements of section 802(b)(3)(B) have been 
    satisfied. Section 802(b)(3)(A) of the act requires that the agency 
    publish a notice in the Federal Register within 10 days of the filing 
    of an application for export to facilitate public participation in its 
    review of the application. To meet this requirement, the agency is 
    providing notice that Merck & Co., West Point, PA 19486, has filed an 
    application requesting approval for the export of the human drug 
    Preservative-Free Intravenous Sodium Edecrin (ethacrynate 
    sodium) 50 mg ethacrynic acid equivalent/50 mL in 60 mL glass bottle to 
    Germany through the Netherlands for packaging and labeling. This 
    product is used in the treatment of accumulation of fluid in tissues 
    (edema, ascites) due to heart, hepatic, or renal disease as well as 
    edemas of the following origin: Edema or ascites caused by tumor 
    compression, lymphedema, and idiopathic edema. The product is being 
    manufactured by a revised process. The firm has new drug application 
    approval for a product containing a thimerosal preservative. The 
    application was received and filed in the Center for Drug Evaluation 
    and Research on May 17, 1995, which shall be considered the filing date 
    for purposes of the act.
        Interested persons may submit relevant information on the 
    application to the Dockets Management Branch (address above) in two 
    copies (except that individuals may submit single copies) and 
    identified with the docket number found in brackets in the heading of 
    this document. These submissions may be seen in the Dockets Management 
    Branch between 9 a.m. and 4 p.m., Monday through Friday.
        The agency encourages any person who submits relevant information 
    on the application to do so by July 24, 1995, and to provide an 
    additional copy of the submission directly to the contact person 
    identified above, to facilitate consideration of the information during 
    the 30-day review period.
        This notice is issued under the Federal Food, Drug, and Cosmetic 
    Act (sec. 802 (21 U.S.C. 382)) and under authority delegated to the 
    Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the 
    Center for Drug Evaluation and Research (21 CFR 5.44).
    
        Dated: June 26, 1995.
     Betty L. Jones,
     Deputy Director, Office of Compliance, Center for Drug Evaluation and 
    Research.
    [FR Doc. 95-17236 Filed 7-12-95; 8:45 am]
    BILLING CODE 4160-01-F
    
    

Document Information

Published:
07/13/1995
Department:
Health and Human Services Department
Entry Type:
Notice
Action:
Notice.
Document Number:
95-17236
Pages:
36151-36152 (2 pages)
Docket Numbers:
Docket No. 95N-0202
PDF File:
95-17236.pdf