[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)] [Notices] [Pages 11107-11108] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-5059] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 95N-0050] Drug Export; Sandostatin (Octreotide Acetate) LarInjection; 10-Milligram (mg), 20-mg, and 30-mg Vials AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that Sandoz Pharmaceuticals Corp. has filed an application requesting conditional approval for the export of the human drug Sandostatin (octreotide acetate) LAR Injection 10-mg, 20-mg, and 30-mg vials to Switzerland for further packaging and marketing. 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, 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 Sandoz Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936-1080, has filed an application requesting approval for the export of the human drug Sandostatin (octreotide acetate) LAR Injection 10-mg, 20-mg, and 30-mg vials to Switzerland. This product is a new formulation of octreotide acetate manufactured by a different process which is indicated for aromegaly, malignant carcinoid syndrome, and vipoma. The firm does have approval for Sandostatin Injection. The [[Page 11108]] application was received and filed in the Center for Drug Evaluation and Research on December 27, 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 March 13, 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: February 9, 1995. Edward Miracco, Acting Deputy Director, Office of Compliance, Center for Drug Evaluation and Research. [FR Doc. 95-5059 Filed 2-28-95; 8:45 am] BILLING CODE 4160-01-F