[Federal Register Volume 60, Number 157 (Tuesday, August 15, 1995)]
[Notices]
[Page 42169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20187]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0247]
Drug Export; DILAUDID HP-PLUS (Hydromorphone Hydrochloride) 20
Milligram (mg)/Milliliter (mL) Vials and DILAUDID XP (Hydromorphone
Hydrochloride) 50mg/mL Vials for Injection
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Knoll Pharmaceutical Co. has filed an application requesting approval
for the export of the human drug DILAUDID HP-PLUS (hydromorphone
hydrochloride) 20mg/mL Vials and DILAUDID XP (hydromorphone
hydrochloride) 50mg/mL Vials for Injection to Canada.
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 Knoll Pharmaceutical Co., 30 North Jefferson Rd.,
Whippany, NJ 07981, has filed an application requesting approval for
the export of the human drug DILAUDID HP-PLUS (hydromorphone
hydrochloride) 20mg/mL Vials DILAUDID XP (hydromorphone hydrochloride)
50mg/mL Vials for Injection to Canada. The firm has an NDA for DILAUDID
10mg/mL (250mg/vial). This product is used for the relief of severe
pain in patients who require subcutaneously, intravenously, or
intramuscularly administered opioids in doses or concentrations higher
than those usually needed. The application was received and filed in
the Center for Drug Evaluation and Research on June 26, 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 August 25, 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 25, 1995.
Betty L. Jones,
Deputy Director, Office of Compliance, Center for Drug Evaluation and
Research.
[FR Doc. 95-20187 Filed 8-14-95; 8:45 am]
BILLING CODE 4160-01-F
