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NY N024771

March 25, 2008



TARIFF NO.: 3004.90.9115

Mr. Mark D. Pinchok
Bayer Corporate and Business Services
100 Bayer Road
Pittsburgh, PA 15205

RE: The tariff classification of Nexavar® in 200 mg tablets from Germany

Dear Mr. Pinchok:

In your letter dated March 14, 2008, on behalf of Bayer Healthcare Pharmaceuticals Inc., you requested a tariff classification ruling.

The subject product Nexavar® is a medicinal preparation containing Sorafenib (CAS-284461-73-0), a multiple kinase inhibitor, as the active ingredient. It is indicated for the treatment of unresectable hepatocellular carcinoma (HCC) in patients with liver cancer and renal cell carcinoma (RCC) in patients with kidney cancer.

The applicable subheading for the Nexavar® in 200 mg tablets will be 3004.90.9115, Harmonized Tariff Schedule of the United States (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 Harvey Kuperstein at 646-733-3033.


Robert B. Swierupski

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