[Federal Register Volume 59, Number 210 (Tuesday, November 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26993]
[[Page Unknown]]
[Federal Register: November 1, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0384]
Drug Export; Lovastatin Bulk Human Drug Substance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Merck & Co., Inc., has filed an application requesting approval for the
export of the bulk human drug substance Lovastatin for formulation into
Mevacor 20 milligrams (mg) and 40 mg tablets to Spain.
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-313), 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 Merck & Co., Inc., P.O. Box 2000, Rahway, NJ
07065, has filed an application requesting approval for the export of
the bulk human drug substance Lovastatin for formulation into Mevacor
20 mg and 40 mg tablets to Spain. While the firm has an approved new
drug application for Lovastatin, the subject of this request was
produced using an unapproved revised process. This product is used as
an adjunct to diet for the reduction of elevated total and low density
lipoproteins (LDL) cholesterol levels in patients with primary
hypercholesterolemia when the response to diet restricted in saturated
fat and cholesterol and to other nonpharmacological measures alone has
been inadequate. The application was received and filed in the Center
for Drug Evaluation and Research on September 19, 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 10, 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 19, 1994.
Raymond E. Hamilton,
Acting Director, Office of Compliance, Center for Drug Evaluation and
Research.
[FR Doc. 94-26993 Filed 10-31-94; 8:45 am]
BILLING CODE 4160-01-F
