The tariff classification of Cabozantinib s-Malate (CAS-1140909-48-3), imported in bulk form and in dosage form

N229135 September 24, 2012 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2933.49.2600, 3004.90.9115 Mr. Joseph Walter Livingston International 670 Young Street Tonawanda, NY 14150 RE: The tariff classification of Cabozantinib s-Malate (CAS-1140909-48-3), imported in bulk form and in dosage form Dear Mr. Walter: In your letter dated July 31, 2012, you requested a tariff classification ruling. Cabozantinib s-Malate, also known as XL184, is the subject of a New Drug Application (NDA) filed with the U.S. Food and Drug Administration (FDA). The FDA has granted priority review, accelerating the approval process for the treatment of metastatic medullary thyroid cancer (MTC). Cabozanitinib s-Malate is a Receptor Tyrosine Kinase Inhibitor (RTKI) which is a potent, targeted therapy that inhibits multiple kinases, including, the met proto-oncogene (MET) and Vascular Endothelial Growth Factor Receptor-2 (VEGFR2). In your letter, you indicated that it is currently undergoing phase III clinical studies for the treatment of metastatic castration-resistant prostate cancer and for the treatment of medullary thyroid cancer. It is also being studied for the treatment of other tumor types such as ovarian cancer, melanoma, breast cancer and non-small cell lung cancer. Pursuant to the General Notice entitled "Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research," published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for the Cabozantinib s-Malate in bulk form will be 2933.49.2600, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) Only: Compounds containing in the structure a quinoline or isoquinoline ring-system (whether or not hydrogenated), not further fused: Other: Other: Drugs: Other.” The rate of duty will be 6.5 percent ad valorem. Pursuant to the General Notice entitled "Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research," published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for the Cabozantinib s-Malate in dosage form will be 3004.90.9115, HTSUS, which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.” The rate of duty will be free. 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 Judy Lee at (646) 733-3033. Sincerely, Thomas J. Russo Director National Commodity Specialist Division