The tariff classification of ZD4054, also known as Zibotentan, (CAS-186497-07-4) in bulk form, from United Kingdom

N030785 June 20, 2008 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2935.00.6000 Ms. Maria Marcos IPR Pharmaceuticals, Inc. P.O. Box 1624 Canovanas, PR 00729-1624 RE: The tariff classification of ZD4054, also known as Zibotentan, (CAS-186497-07-4) in bulk form, from United Kingdom Dear Ms. Marcos: In your letter dated June 10, 2008, you requested a tariff classification ruling. The subject product, ZD4054, also known as Zibotentan, is an orally active Endothelin A (ETA) receptor antagonist. It is currently in Phase III clinical trials for the treatment of prostate cancer. According to your letter, ZD4054 works by specific blockade of the ETA receptor. It inhibits multiple processes in cancer such as tumor cell proliferation, tumor cell survival, tumor angiogenesis and the pathophysiology of bone metastases. The applicable subheading for the ZD4054, in bulk form, will be 2935.00.6000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Sulfonamides: Other: Drugs: Other." Pursuant to General Note 13, HTSUS, the rate of duty will be free. Zibotentan is listed as N-(3-methoxy-5-methylpyrazin-2-yl)-2-(4-[1,3,4-oxadiazol-2-yl]phenyl)pyridine-3-sulfonamide in the pharmaceutical appendix. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division