[Federal Register Volume 60, Number 96 (Thursday, May 18, 1995)]
[Notices]
[Page 26731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12177]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0123]
Drug Export; ReviaTM (Naltrexone Hydrochloride (HCl)) 50
Milligrams (mg) Film-Coated Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Dupont Merck has filed an application requesting approval for the
export of the human drug ReviaTM (naltrexone HCl) 50 mg film-
coated tablets to Germany.
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 20857, 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 Dupont Merck, Dupont Merck Plaza, Maple Run,
Centre Rd., Wilmington, DE 19805, has filed an application requesting
approval for the export of the human drug ReviaTM (naltrexone HCl)
50 mg film-coated tablets to Germany. The firm holds an approved new
drug application for an uncoated tablet, however, this application is
for a new film-coated tablet formulation. This product is used as an
adjunctive treatment of opioid dependence in detoxified, formerly
opioid dependent individuals, and in a proposed indication as an
adjunctive treatment for individuals with alcohol dependence undergoing
psychosocial treatment programs. The application was received and filed
in the Center for Drug Evaluation and Research on April 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 May 30, 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: May 4, 1995.
Gayle R. Dolecek,
Acting Director, Office of Compliance, Center for Drug Evaluation and
Research.
[FR Doc. 95-12177 Filed 5-17-95; 8:45 am]
BILLING CODE 4160-01-F
