[Federal Register Volume 60, Number 139 (Thursday, July 20, 1995)]
[Notices]
[Page 37454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17786]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0209]
Drug Export; CellCept (Mycophenolate Mofetil) 500 Milligram (mg)
Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Syntex Laboratories has filed an application requesting conditional
approval for the export of the human drug CellCept (mycophenolate
mofetil) 500 mg tablets to the European Union (EU) member countries
(Austria, Belgium, Denmark, Germany, Finland, France, Ireland, Italy,
Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom)
through Switzerland for 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.
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 Syntex Laboratories, 3401 Hillview Ave., P.O. Box
10850, Palo Alto, CA 94303, has filed an application requesting
conditional approval for the export of the human drug CellCept
(mycophenolate mofetil) 500 mg tablets to the EU member countries
(Austria, Belgium, Denmark, Germany, Finland, France, Ireland, Italy,
Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom)
through Switzerland for packaging and labeling. CellCept (mycophenolate
mofetil) is indicated for the prophylaxis of organ rejection and for
the treatment of refractory organ rejection in patients receiving
allogenic renal transplants. The application was received and filed in
the Center for Drug Evaluation and Research on May 22, 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 31, 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: July 10, 1995.
Betty L. Jones,
Deputy Director, Office of Compliance, Center for Drug Evaluation and
Research.
[FR Doc. 95-17786 Filed 7-19-95; 8:45 am]
BILLING CODE 4160-01-F
