CLA-2-29:OT:RR:NC:2:238

Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753

RE: The tariff classification of Enzalutamide (CAS 915087-33-1), in bulk form, from Italy

Dear Ms. Forstenzer:

In your letter dated May 30, 2014, you requested a tariff classification ruling.

The subject product Enzalutamide is an androgen receptor antagonist. This drug is indicated for the treatment of metastatic castration-resistant cancer for patients who have previously used Dosetaxel.

The applicable subheading for the Enzalutamide in bulk form will be 2933.29.2000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for which provides for Heterocyclic compounds with nitrogen hetero-atom(s)only: Compounds containing an unfused imidazole ring (whether or not hydrogenated) in the structure: Other: Aromatic or modified aromatic: Other: Drugs. The rate of duty will be 6 percent ad valorem.

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 [email protected].

Sincerely,

Gwenn Klein Kirschner
Director
National Commodity Specialist Division