HERTFORDSHIRE, England and
PITTSBURGH, Dec. 29, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL), today announced the U.S. launch of
Fosphenytoin Sodium Injection USP, 75 mg/mL, (50 mg PE*/mL),
packaged in 100 mg PE*/2 mL, and 500 mg PE*/10 mL single-use vials,
a generic version of Pfizer's Cerebyx® Injection. Mylan received
final approval from the U.S. Food and Drug Administration (FDA) for
its Abbreviated New Drug Application (ANDA) for this product, for
the treatment of certain types of severe seizures. (1)
Fosphenytoin Sodium Injection USP, 75 mg/mL, (50 mg PE*/mL),
packaged in 100 mg PE*/2 mL, and 500 mg PE*/10 mL single-use vials
had U.S. sales of approximately $36.3
million for the 12 months ending October 31, 2016, according to IMS Health.
The product is part of Mylan's growing global portfolio of more
than 450 injectable products, which includes liquid, lyophilized
and dry-powder formulations delivered in a range of mechanisms
including ampoules, vials, ready-to-use bags and pre-filled
syringes. Mylan's global network of nine injectable facilities
produces hundreds of millions of doses each year.
Currently, Mylan has more than 240 ANDAs pending FDA approval
representing approximately $95.6
billion in annual brand sales, according to IMS Health.
Forty-one of these pending ANDAs are potential first-to-file
opportunities, representing $32.5
billion in annual brand sales, for the 12 months ending
June 30, 2016, according to IMS
Health.
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 2,700 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS worldwide depend. We market our
products in more than 165 countries and territories. Our global
R&D and manufacturing platform includes more than 50
facilities, and 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.
PE* = Phenytoin Sodium Equivalents
(1) Cardiovascular risk is associated with rapid infusion rates.
The rate of intravenous Cerebyx® administration should not exceed
150 mg phenytoin sodium equivalents (PE) per minute because of the
risk of severe hypotension and cardiac arrhythmias. Careful cardiac
monitoring is needed during and after administering intravenous
Cerebyx®. Although the risk of cardiovascular toxicity increases
with infusion rates above the recommended infusion rate, these
events have also been reported at or below the recommended infusion
rate. Reduction in rate of administration or discontinuation of
dosing may be needed
This press release includes statements that constitute
"forward-looking statements," including with regard to the
Company's injectables portfolio. 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: any changes in or
difficulties with Mylan's or its partners' ability to develop,
manufacture, and commercialize products; any regulatory, legal, or
other impediments to Mylan's or its partners' ability to bring
products to market; actions and decisions of healthcare and
pharmaceutical regulators, and changes in healthcare and
pharmaceutical laws and regulations, in the United States and abroad; 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 these
statements for revisions or changes after the date of this
release.
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SOURCE Mylan N.V.