Benchmarks

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
Rockville, MD 20857

IND 33,729

Takeda Pharmaceuticals North America, Inc.
Attention: Janet L. Haskins
Manager, Regulatory Affairs
475 Half Day Road, Suite 500
Lincolnshire, IL 60069

RECEIVED
REGULATORY AFFAIRS DEPARTMENT

JUN 16 2003

Takeda Pharmaceuticals North America, Inc.

Dear Ms. Haskins:

Please refer to your Investigational New Drug Application (IND) submitted January 15, 1999, under section 505(i) of the Federal Food, Drug, and Cosmetic Act for Actos (pioglitazone HCl) Tablets, 15 mg, 30 mg and 45 mg.

We also refer to your amendment dated May 8, 2003 (serial # 525), received on May 9, 2003, that provided a response to our November 13, 2002, letter which cited the reasons this protocol was placed on clinical hold and the information needed to resolve the clinical hold issues.

We have completed the review of your submission and have concluded that removal of the clinical hold is not warranted. We acknowledge your agreement to monitor for bladder tumors in your clinical studies, and to amend the label and consent documents. However, until further information on bladder effects from ongoing studies is available, we do not believe studies in pediatric patients are warranted.

Until you have submitted the required information and we notify you that you may initiate trials, this IND remains on clinical hold and you may not legally conduct clinical studies under it.

Please identify your response to the clinical hold issues as a "CLINICAL HOLD COMPLETE RESPONSE." To facilitate a response to your submission, submit this information in triplicate to the IND. In addition, send a copy of the cover letter to Ms. Jena Weber.

Following receipt of your complete response to these issues, we will notify you of our decision within 30 days.

424

Confidential – Subject to Protective Order

TAK-INDNDA-01577085
Produced in MDL on 01/31/13

Source: https://www.industrydocuments.ucsf.edu/docs/xyjf0226