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.
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.