HERTFORDSHIRE, England and
PITTSBURGH, March 25, 2020 /PRNewswire/ -- Mylan
(NASDAQ: MYL) today announced that, in its ongoing effort to
support patients and public health needs in the current
unprecedented circumstances surrounding the COVID-19 pandemic,
Mylan has voluntarily waived its exclusive rights in the U.S. to
distribute its generic version of Kaletra®
(lopinavir/ritonavir) antiretroviral 100mg/25mg and 200mg/50mg
tablets to help increase the available supply of the product should
it prove effective in the treatment of coronavirus. By doing
so, Mylan will enable other generic applicants to be eligible for
FDA approval of their medicines for patients in the U.S., expanding
access in the event that additional clinical studies or other
evaluations conclude that the product may be effective in treating
COVID-19.
Mylan was the first company to file a substantially complete
abbreviated new drug application with the Food and Drug
Administration (FDA) to bring a generic version of this product to
market, entitling the company to a 180-day marketing exclusivity
period upon final FDA approval, which is pending.
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
40% of people being treated for HIV/AIDS globally 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 approximately 35,000-strong
workforce is dedicated to creating better health for a better
world, one person at a time. Learn more at Mylan.com. We routinely
post information that may be important to investors on our website
at investor.mylan.com.
Forward-Looking Statement
This press release includes statements that constitute
"forward-looking statements," including with regard to regulatory
approvals, market exclusivity and the potential approval and/or use
of generic Kaletra® (lopinavir/ritonavir) antiretroviral tablets in
the treatment of COVID-19. Because forward-looking statements
inherently involve risks and uncertainties, actual future results
may differ materially from those expressed or implied by such
statements. Factors that could cause or contribute to such
differences include, but are not limited to the impact of the
COVID-19 pandemic; the timing or outcome of FDA review and
approval; actions and decisions of healthcare and pharmaceutical
regulators; changes in healthcare, pharmaceutical or other 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.