Viewing data from:

CYLERT

NDA

PEMOLINE | N016832 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV

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
Citizen Petition from Public Citizen FDA-2005-P-0256 · 6 docket documents Public Citizen filed this citizen petition on March 24, 2005, pursuant to 21 U.S.C. Section 355(e)(3), requesting that the FDA immediately withdraw pemoline (CYLERT and generic versions) from the market due to its association with at least 21 cases of liver failure including 13 deaths or transplanta	Other	2017-08-29	Denied	Public Citizen

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

Clinical Trials

2 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pemoline for Cocaine Abuse - 7 NCT00000282	Phase 2	Completed	Yale University	—	1994-09 → 1999-08
Pemoline in the Treatment of Stimulant Dependence - 5 NCT00000340	Phase 2	Withdrawn	National Institute on Drug Abuse (NIDA)	—	1996-06

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

API Supply Chain1 active DMF5 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

KATWIJK CHEMIE BVPEMOLINE

DMF 117801995

HOECHST CELANESE CORPInactivePEMOLINE

DMF 122381996

ORGAMOL SAInactivePEMOLINE

DMF 127961997

MALLINCKRODT INCInactivePEMOLINE MALLINCKRODT CODE 1500

DMF 138651998

PLIVA DDInactivePEMOLINE

DMF 139191998

INNOVATIVE PHARMACY SOLUTIONS LLCInactivePEMOLINE 18.75 MG COMPOUNDED CAPSULES

DMF 312682016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 25, 2003	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 18.75MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 37.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 75MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982