Extended-Release and Long-Acting (ER/LA) Opioid Analgesics
Risk Evaluation and Mitigation Strategy (REMS)

REMS Program Companies (RPC) Statement:

The REMS Program Companies (RPC) support this Risk Evaluation and Mitigation Strategy (REMS) aspart of national efforts to address the epidemic of prescription drug abuse in the United States. The RPC has been actively involved in providing input to the U.S. Food and Drug Administration (FDA) as it developed the class-wide REMS. The REMS provides a structure for all of the companies of the RPC toefficiently implement risk evaluation and mitigation activities across all extended-release and long-acting (ER/LA) opioid analgesics in a uniform manner.

In the interest of public health and to minimize the burden on the healthcare delivery system from having multiple unique REMS programs, pharmaceutical companies subject to this REMS have joined together to implement this REMS for all extended-release and long-acting opioid analgesic drug products.

We look forward to continuing our activities to help mitigate the risks of misuse and abuse without impeding access to these important medications for appropriate patients.

ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Overview

In April 2011, the FDA determined that a class-wide REMS was necessary for all ER/LA opioid analgesics to support national efforts to address the prescription drug abuse epidemic and to ensure that the benefits continue to outweigh the risks of adverse outcomes resulting from inappropriate prescribing, abuse, and misuse of these medications. (A REMS is a strategy to manage a known or potential serious risk associated with a drug product.)

The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse and abuse of ER/LA opioid analgesics while maintaining patient access to pain medications. Adverse outcomes include addiction, unintentional overdose, and death.

In the interest of public health and to minimize the burden on the healthcare delivery system from having multiple unique REMS programs, pharmaceutical companies subject to this REMS joined together toimplement this REMS for all ER/LA opioid drug products.

The principle components of this REMS are for all companies with ER/LA opioid analgesics to provide:

a) access to Prescriber training on all ER/LA opioid analgesics,
b) the Patient Counseling Document on Extended-Release and Long-Acting Opioid Analgesics             (PCD), and
c) a unique Medication Guide for each ER/LA opioid analgesic drug product.

The branded and generic drug products for which this REMS is required include all:

• extended-release, oral-dosage forms containing
  • hydromorphone
  • morphine
  • oxycodone
  • oxymorphone
  • tapentadol
• fentanyl and buprenorphine-containing transdermal delivery systems; and
• methadone tablets and solutions that are indicated for use as analgesics.

More information on all the components of the class-wide REMS is available on the FDA website and at the ER/LA Opioid Analgesic REMS website: www.ER-LA-OpioidREMS.com

About Roxane Laboratories, Inc.

Roxane Laboratories is located in Columbus, OH in a modern 500,000 square foot manufacturing and laboratory facility. The facility spans 70 acres and currently employs over 1,200 people. Currently, Roxane Laboratories markets over 80 medications in nearly 300 package sizes, focusing on an expanding line of Multisource pharmaceutical products including: bulk and unit-dose liquids and solids; coated, sustained-release and controlled-release tablets; nasal sprays, cytotoxics and CII narcotics.

Roxane Laboratories, Inc., is a subsidiary of Boehringer Ingelheim Corporation, based in Ridgefield, CT anda member of the Boehringer Ingelheim group of companies.

For more information, please visit http://www.Roxane.com.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.