[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