[Federal Register Volume 59, Number 212 (Thursday, November 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27317]


[[Page Unknown]]

[Federal Register: November 3, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0396]

 

Drug Export; Vitinoin (Tretinoin) Gel 0.025% and Vitinoin 
(Tretinoin) Cream 0.025%, 0.05%, 0.1%

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Penederm, Inc., has filed an addendum application requesting approval 
for the export of the human drug Vitinoin (tretinoin) Gel 0.025% and 
Vitinoin (tretinoin) Cream 0.025%, 0.05%, 0.1% to Canada. The FDA had 
received a previous application on March 7, 1994, from Penederm, Inc., 
which was published in the Federal Register of May 13, 1994, requesting 
approval for the export of the human drug Acticin (tretinoin) Gel 
0.025% to Canada. This notice announces a product name change, the 
addition of the cream formulations and a change in the manufacturing 
site.

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, Division of Drug 
Labeling Compliance (HFD-313), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-2073.

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 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 Penederm, Inc., 320 Lakeside Dr., suite A, Foster 
City, CA 94404, has filed an addendum application requesting approval 
for the export of the human drug Vitinoin (tretinoin) Gel 0.025% and 
Vitinoin (tretinoin) Cream 0.025%, 0.05%, 0.1%. This product is 
indicated for topical application in the treatment of acne vulgaris, 
primarily where comedones, papules and pustules predominate. The 
addendum application was received and filed in the Center for Drug 
Evaluation and Research on September 9, 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 November 14, 1994, 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: October 21, 1994.
Raymond E. Hamilton,
Acting Director, Office of Compliance, Center for Drug Evaluation and 
Research.
[FR Doc. 94-27317; Filed 11-2-94; 8:45 am]
BILLING CODE 4160-01-F