Mylan Confirms U.S. Launch Of First Generic For Copaxone 40 Mg/Ml 3-Times-A-Week And Generic For Copaxone 20 Mg/Ml Once-Daily

Published: Oct 05, 2017

HERTFORDSHIRE, England, and PITTSBURGH, Oct. 4, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today confirmed that the company has launched in the U.S. the first Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection that is an AP-rated substitutable generic version of Teva's Copaxone® 40 mg/mL, as well as Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva's Copaxone® 20 mg/mL. These products are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. Shipments to customers have commenced.

Mylan (PRNewsfoto/Mylan N.V.)

INDICATION    
GLATIRAMER ACETATE INJECTION is a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS).

IMPORTANT SAFETY INFORMATION   
Do not take GLATIRAMER ACETATE INJECTION if you are allergic to glatiramer acetate or mannitol.    

Some patients report a short-term reaction right after injecting glatiramer acetate.  This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and do not require specific treatment.  There have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, call the emergency phone numbers in your area.

Call your doctor right away if you develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, do not give yourself any more injections until your doctor tells you to begin again.

Chest pain may occur either as part of the immediate post-injection reaction or on its own. This pain should only last a few minutes. You may experience more than one such episode, usually beginning at least one month after starting treatment.  Tell your doctor if you experience chest pain that lasts for a long time or feels very intense.

A permanent indentation under the skin (lipoatrophy and, rarely, death of your skin tissue also referred to as necrosis) at the injection site may occur due to local destruction of fat tissue. Be sure to follow proper injection technique and inform your doctor of any skin changes.  

The most common side effects in studies of GLATIRAMER ACETATE INJECTION are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.  These are not all of the possible side effects of GLATIRAMER ACETATE INJECTION. For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects that you have while taking GLATIRAMER ACETATE INJECTION.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, Patient Information Leaflet, and Instructions for Use for GLATIRAMER ACETATE INJECTION 20 mg/mL and 40 mg/mL.

Forward-Looking Statements 
This press release includes statements that constitute "forward-looking statements," including with regard to the launch of Mylan's Glatiramer Acetate Injection products. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; actions and decisions of healthcare and pharmaceutical regulators; determinations by health insurance companies regarding coverage for Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL; any regulatory, legal, or other impediments to Mylan's ability to bring Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL to market, including ongoing and unresolved allegations of patent infringement around our launch of Glatiramer Acetate Injection, 40 mg/mL; any changes in or difficulties with Mylan's or its partners' inventory of, and ability to manufacture and distribute, Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL to meet anticipated demand; the potential impact of any change in patient access to or demand for Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL; the scope, timing, and outcome  of any ongoing legal proceedings, including but not limited to government investigations, and the impact of any such proceedings on Mylan's or its partners' business; potential forfeiture of exclusivity periods for failure to obtain tentative approval; the impact of competition; strategies by competitors or other third parties to delay or prevent product introductions; changes in the economic and financial conditions of the businesses of Mylan or its partners; other uncertainties and matters beyond the control of management; and the other risks detailed in Mylan's filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update any statements herein for revisions or changes after the date of this release.

About Mylan 
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.

Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd. The Mylan Better Health for a Better World logo is a trademark of Mylan Inc.

©2017 Mylan Pharmaceuticals Inc. All rights reserved. GA-2017-0068

 

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SOURCE Mylan N.V.

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