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TAKEDA PHARMACEUTICALS NORTH AMERICA INC.
November 18, 2002
David Orloff, M.D.
Division of Metabolic & Endocrine Drug Products (HFD-$10)
Office of Drug Evaluation II
Center for Drug Evaluation & Research
Document Control Room 148-19
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
ACTOS (pioglitazone HCI) Tablets, 15, 30 and 45-mg
Serial No. 501
Dear Dr. Orloff:
Response to FDA Request for Information
Reference is made to a telephone conference call held between Drs. Orloff, Misbin and
El-Hage and Ms. Jena Weber, of the Division and representatives from Takeda
Pharmaceuticals North America, Inc. (TPNA) on July 31, August 13, November 1 and 6,
2002 and submissions made to the above noted IND on August 28, and September 27,
2002 (Serial Nos. 485 and 490, respectively).
During the conference call with Division members on November 6th, Dr. Orloff
requested that TPNA break the study medication blind on the two patients that were
reported to the IND on September 27". The purpose of this submission is to comply with
the Division request. Information on these patients was previously submitted to the
Agency in a blinded fashion as Serial Number 490. The case histories followed by the
drug treatment are detailed below. Both patients have been discontinued from the study.
Case Number One:
A 58 year old male, enrolled in the study for 103 days, was hospitalized for a urinary
tract obstruction, which was later diagnosed as bladder cancer. This patient had a two
year intermittent history of hematuria with dysuria and urinary retention, urinary tract
infections, hemorrhagic cysitis and enlarged prostate. The patient has been
discontinued from the trial and there is no available information on tobacco use or
exposure to other chemicals.
Drug Treatment: Ploglitazone HCI
EXHIBIT
Bhattacharya
39
475 Half Day Road. Suite 500
Lincolnshire, Illinois 60069
Phone: 847-383- 1080
70-27-13
Confidential - Subject to Protective Order
TAK-INDNDA-01273547
Produced in MDL on 09/11/2012
Source: https://www.induptus/qcooouts.ucsf.edu/docs/gyjf0226

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