PITTSBURGH, Aug. 28, 2014 /PRNewswire/ -- Mylan Inc.
(Nasdaq: MYL) today announced that its abbreviated new drug
application (ANDA) for a three times per week Glatiramer Acetate
Injection 40 mg/mL has been accepted for filing by the U.S. Food
and Drug Administration (FDA). This product is the generic version
of Teva's Copaxone® 40 mg/mL, which is indicated for the treatment
of patients with relapsing forms of multiple sclerosis (MS).
Mylan believes it is one of the first companies to have filed a
substantially complete ANDA containing a Paragraph IV certification
for this product and expects to be eligible for 180 days of
marketing exclusivity in the U.S. upon final FDA approval.
Copaxone 40 mg/mL had U.S. sales of approximately $411.5 million for the 12 months ending
June 30, 2014, according to IMS
Health.
Currently, Mylan has 294 ANDAs pending FDA approval representing
$105.7 billion in annual brand sales,
according to IMS Health. Forty-three of these pending ANDAs are
potential first-to-file opportunities, representing $25.0 billion in annual brand sales, for the 12
months ending Dec. 31, 2013,
according to IMS Health.
This press release includes statements that constitute
"forward-looking statements," including with regard to sales of
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: strategies by competitors or other third parties to
delay or prevent product introductions; risks inherent in legal and
regulatory processes; and the other risks detailed in the company's
filings with the Securities and Exchange Commission. The company
undertakes no obligation to update these statements for revisions
or changes after the date of this release.
Mylan is a global pharmaceutical company committed to setting
new standards in health care. 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 1,300 generic pharmaceuticals and several
brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately 40% of HIV/AIDS
patients in developing countries depend. We also operate one of the
largest active pharmaceutical ingredient manufacturers and
currently market products in approximately 140 countries and
territories. Our workforce of more than 20,000 people is dedicated
to improving the customer experience and increasing pharmaceutical
access to consumers around the world. But don't take our word for
it. See for yourself. See inside. mylan.com
Copaxone® is a registered trademark of Teva Pharmaceutical
Industries Ltd.
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SOURCE Mylan Inc.