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NY F89937




August 8, 2000

CLA-2-29:RR:NC:2:238 F89937

CATEGORY: CLASSIFICATION

TARIFF NO.: 2932.99.9000; 3004.90.9010

Robert L. Eisen, Esq.
Christopher E. Pey, Esq.
Coudert Brothers
1114 Avenue of the Americas
New York, NY 10036-7703

RE: The tariff classification of Zanamivir (CAS-139110-80-8), imported in bulk form, and RELENZA® (zanamivir for inhalation), from the United Kingdom, France, Italy, Canada, Singapore, etc.

Dear Messrs. Eisen and Pey:

In your letter dated April 25, 2000, resubmitted July 18, 2000, on behalf of your client, Glaxo Wellcome Inc., you requested a tariff classification ruling.

The first product, Zanamivir, is an antiviral drug indicated for use in the treatment of influenza. You state in your letter that your client’s New Drug Application (NDA) for Zanamivir has been approved by the U.S. Food & Drug Administration (FDA).

The second product, RELENZA® (zanamivir for inhalation) is a medicament containing Zanamivir as the active ingredient. It is administered, by oral inhalation, to the respiratory tract. In its condition as imported, it consists of a DISKHALER® inhalation device, and five (5) ROTADISKS® (a circular double-foil pack containing 4 blisters of medication). The ROTADISKS® are packaged in a white polypropylene tube. The polypropylene tube containing the five ROTADISKS® is, in turn, packaged in a carton, along with one (1) DISKHALER® inhalation device, for retail sale. The product is described in your client’s product literature as follows: “[E]ach RELENZA ROTADISK® contains 4 regularly spaced double-foil blisters with each blister containing a powder mixture of 5 mg of zanamivir and 20 mg of lactose. The contents of each blister are inhaled using a specially designed breath-activated device for inhaling powder called the DISKHALER. After a RELENZA ROTADISK is loaded into the DISKHALER a blister that contains medication is pierced and the zanamivir is dispersed into the air stream created when the patient inhales through the mouthpiece.”

The applicable subheading for Zanamivir, imported in bulk form, will be 2932.99.9000, Harmonized Tariff Schedule of the United States (HTS), which provides for "[H]eterocyclic compounds with oxygen hetero-atom(s) only: Other: Other: Other: Other." Pursuant to General Note 13, HTS, the rate of duty will be free.

The applicable subheading for RELENZA® (zanamivir for inhalation) will be 3004.90.9010, HTS, which provides for “[M]edicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Anti-infective medicaments: Other.” The general rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

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 212-637-7068.

Sincerely,

Robert B. Swierupski

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