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NDA

TROGLITAZONE | N020719 | SANKYO USA CORP

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from Public Citizen Health Group FDA-2000-P-1218 · 4 docket documents Public Citizen Health Group filed this citizen petition on March 7, 2000, pursuant to 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30, requesting that the FDA immediately require revised professional labeling for the thiazolidinedione diabetes drugs troglitazone (Rezulin), rosiglitazone (Avandia), a	Other	2011-02-17	Partially Denied	Public Citizen Health Group

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

3 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies NCT01068860	Phase 2	Completed	Novartis	246	2010-02 → 2010-08
TART - Troglitazone Atherosclerosis Regression Trial NCT00116545	Phase 2/3	Completed	Parke-Davis	288	1997-01 → 2000-04
Troglitazone in Treating Patients With Liposarcoma NCT00003058	Phase 2	Completed	Dana-Farber Cancer Institute	85	1997-06 → 2000-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 1, 1999	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 29, 1997

No patent or exclusivity listings for this strength.

#002 — 400MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 29, 1997

#003 — 300MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 4, 1997