[Federal Register Volume 60, Number 28 (Friday, February 10, 1995)]
[Notices]
[Pages 7975-7976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3440]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0030]
Drug Export; Remydrial Two Component System Containing
Dapiprazole Hydrochloride 50 Milligram (mg) in 260 mg Lyophilized
Powder and Solvent Containing 1.0 mg Benzalkonium Chloride
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Angelini Pharmaceuticals, Inc., has filed an application requesting
approval for the export of the human drug Remydrial two
component system containing Dapiprazole Hydrochloride 50 milligram (mg)
in 260 mg Lyophilized powder and solvent containing 1.0 mg Benzalkonium
Chloride in 10 milliliter (mL) bottle 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, 5600
Fishers Lane, Rockville, MD 20857, 301594-2073.
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 [[Page 7976]] 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 Angelini
Pharmaceuticals, Inc., 70 Grand Ave., River Edge, NJ 07661, has filed
an application requesting approval for the export of the human drug
Remydrial two component system containing Dapiprazole
Hydrochloride 50 mg in 260 mg Lyophilized powder and solvent containing
1.0 mg Benzalkonium Chloride in 10 mL bottle to Germany. The firm
currently holds an approved new drug application for this product,
however, this preparation contains modifications which consists of a
formulation change in the solvent for isotonicity, a change in the
package size and design for ease of use, and a change in the
manufacturer. This product is used for the reversal of medicine-induced
pupil dilation. The application was received and filed in the Center
for Drug Evaluation and Research on November 22, 1994, 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 February 21, 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: January 31, 1995.
Kathy P. Miracco,
Acting Director, Office of Compliance, Center for Drug Evaluation and
Research.
[FR Doc. 95-3440 Filed 2-9-95; 8:45 am]
BILLING CODE 4160-01-F
