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NY F86215




June 12, 2000

CLA-2-29:RR:NC:2:238 F86215

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.39.4100

Robert H. Schor, Esq.
Barnes, Richardson & Colburn
475 Park Avenue South
New York, NY 10016

RE: The tariff classification of LU 25-109-M, imported in bulk form, from Denmark

Dear Mr: Schor

In your letter dated April 18, 2000, on behalf of your client, Forest Laboratories, Inc.you requested a tariff classification ruling.

The subject product, code-named “LU 25-109-M,” is an investigational new drug (IND #58,989) which will be imported by your client for use in clinical trials (Phase 3) to ascertain its efficacy in the treatment of patients who exhibit symptoms of an overactive bladder. Chemically, LU 25-109-M is known as 2-Ethyl-5-(1-methyl-1,2,5,6-tetrahydro-3-pyridyl)-2H-tetrazol, maleate (CAS number: not available). You indicate that the international nonproprietary name (INN) for LU 25-109-M is Alvameline, which, at the present time, is not listed in Table 1 of the Pharmaceutical Appendix to the Tariff Schedule.

The applicable subheading for LU 25-109-M, imported in bulk form, will be 2933.39.4100, Harmonized Tariff Schedule of the United States (HTS), which provides for "[H]eterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other." Pursuant to General Note 13, HTS, the rate of duty will be 6.5 percent ad valorem.

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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