Viewing data from:

ORLAAM

NDA

LEVOMETHADYL ACETATE HYDROCHLORIDE | N020315 | ROXANE LABORATORIES INC

1 strength0 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

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Virginia Commonwealth University (VCU), School of Medicine - Citizen Petition FDA-2010-P-0505 · 6 docket documents Virginia Commonwealth University's School of Medicine, filed a petition on September 21, 2010 requesting that the FDA determine whether levomethadyl acetate HCl (Orlaam®) NDA 20-315 held by Roxane Laboratories Inc. was voluntarily withdrawn for safety or efficacy reasons, and to confirm Orlaam® oral	505(q)	2010-09-29	Granted	—
VCU School of Medicine - Citizen Petition FDA-2007-P-0175 · 3 docket documents VCU School of Medicine filed this citizen petition pursuant to Section 505(j)(2)(C) requesting that the FDA determine levomethadyl acetate HCl tablets in 10mg, 20mg, and 40mg strengths are suitable for submission as an ANDA, with Orlaam oral solution as the reference listed drug, based on the change	Other	2008-05-06	Open	—
Epidemiology and Community Health vcu School of Medicine - Citizen Petition FDA-2007-P-0347 · 5 docket documents The Virginia Commonwealth University School of Medicine's Department of Epidemiology and Community Health, filed by Professor Charles O'Keeffe, submitted a citizen petition requesting that the FDA Commissioner determine whether levomethadyl acetate HCl (Orlaam) under NDA 20-315, held by Roxane Labor	505(q)	2008-04-23	Granted	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs1 inactive

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

ORPHARM INCInactiveLEVOMETHADYL ACETATE HYDROCHLORIDE (LAAM HCL)

DMF 127411997

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 30, 2001	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CONCENTRATE;ORAL | Approved: Jul 9, 1993

No patent or exclusivity listings for this strength.