HERTFORDSHIRE, England and
PITTSBURGH, Aug. 8, 2017 /PRNewswire/ -- Mylan
Pharmaceuticals Private Limited, a subsidiary of Mylan N.V.
(NASDAQ, TASE: MYL), a leading global pharmaceutical company, has
received marketing authorization from the Drug Controller General
of India (DCGI) for its
antiretroviral (ARV) drug Avonza™ (TLE400). Avonza™ is a fixed-dose
combination comprised of Efavirenz, Lamivudine and Tenofovir
Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg, recommended by
the World Health Organization (WHO) as an alternative first-line
regimen for people being treated for HIV/AIDS.
Commenting on the launch, Mylan President Rajiv Malik said, "Developing Avonza™ and
bringing it to patients with HIV in India is a continuation of our strong and
sustained commitment to expanding access to affordable, high
quality ARVs. Avonza™ will be available to patients at a cost that
is lower than that of other current first-line ARVs. What's more,
Mylan is the first to offer this combination in India, making it another example of the
innovative spirit that runs throughout our company to adapt our
medicines, accelerate access and improve treatment outcomes."
In April 2017, the Health Ministry
in India launched the Test and
Treat Policy for HIV; anyone testing positive for HIV will get
antiretroviral therapy irrespective of CD4 count or clinical
stage.
Mylan's Avonza™ also is another step the company is taking to
help India meet its Sustainable
Development Goal of ending AIDS by 2030.
Globally, Mylan supplies life-saving ARVs to nearly 50% of
patients being treated for HIV/AIDS in more than 100 developing
countries. The company's comprehensive ARV portfolio includes 14
active pharmaceutical ingredients and 50 finished dosage forms in
first-line, second-line and pediatric formulations.
THE HIV EPIDEMIC IN INDIA
- In 2015, it was estimated that 21.17 lakh people living in
India have HIV
- Of that, 6.5% are children under age 15
- Among the States / Union Territories, Manipur showed the
highest estimated adult HIV prevalence (1.15%)
- This was followed by Mizoram (0.80%), Nagaland (0.78%), Andhra
Pradesh and Telangana (0.66%), Karnataka (0.45%), Gujarat (0.42%)
and Goa (0.40%)
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.
This press release includes statements that constitute
"forward-looking statements," including with regard to Avonza™
being available to patients at a cost that is lower than that of
other current first-line ARVs. 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: success of clinical
trials and our or our partners' ability to execute on new product
opportunities; any regulatory, legal or other impediments to our or
our partners' ability to bring products to market; other risks
inherent in product development; the scope, timing, and outcome of
any ongoing legal proceedings, including government investigations,
and the impact of any such proceedings on our or our partners'
businesses; actions and decisions of healthcare and pharmaceutical
regulators, and changes in healthcare and pharmaceutical laws and
regulations, in the United
States, India and abroad; the impact of
competition; strategies by competitors or other third parties to
delay or prevent product introductions; the effect of any changes
in our or our partners' customer and supplier relationships and
customer purchasing patterns; any other changes in third-party
relationships; changes in the economic and financial conditions of
the businesses of Mylan or its partners; 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.