[Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
[Notices]
[Pages 45162-45163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21453]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0270]
Drug Export; Anzemet (Dolasetron Mesilate) Bulk Drug Substance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that
Marian Merrell Dow Inc., has filed an application requesting
conditional approval for the export of Anzemet (dolasetron Mesilate)
Bulk Drug Substance to Italy for the preparation and packaging of the
following injectable dose strengths 12.5 milligrams (mg), 25 mg, 50 mg,
100 mg, and 200 mg for transshipment to the United Kingdom.
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
[[Page 45163]]
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 Marian Merrell Dow
Inc., Marian Park Dr., P.O. Box 9627, Kansas City, MO 64134-0627, has
filed an application requesting conditional approval for the export of
Anzemet (dolasetron Mesilate) Bulk Drug Substance to Italy for the
preparation and packaging of the following injectable dose strengths
12.5 mg, 25 mg, 50 mg, 100 mg, and 200 mg for transshipment to the
United Kingdom. Anzemet (dolasetron Mesilate) injection is indicated
for nausea and vomiting in patients receiving initial and repeat
courses of cancer chemotherapy (including high dose cisplatin) or
radiotherapy and for post operative nausea and vomiting. The
application was received and filed in the Center for Drug Evaluation
and Research on August 8, 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 September 11, 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: August 11, 1995.
Betty L. Jones,
Deputy Director, Office of Compliance, Center for Drug Evaluation and
Research.
[FR Doc. 95-21453 Filed 8-29-95; 8:45 am]
BILLING CODE 4160-01-F------
