HERTFORDSHIRE, England, and
PITTSBURGH, May 10, 2019 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today
announced the U.S. launch of Erlotinib Hydrochloride Tablets, 25
mg, 100 mg and 150 mg, a generic version of Genentech's
Tarceva®. Mylan Pharmaceuticals received final approval
from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for this product.
Erlotinib Hydrochloride Tablets is indicated for the treatment
of patients with metastatic non-small cell lung cancer whose tumors
have epidermal growth factor receptor (EGFR) exon 19 deletions or
exon 21 (L858R) substitution mutations as detected by an
FDA-approved test receiving first-line, maintenance, or second or
greater line treatment after progression following at least one
prior chemotherapy regimen. The safety and efficacy of erlotinib
has not been established in patients with NSCLC whose tumors have
other EGFR mutations. It is also indicated as a first-line
treatment for patients with locally advanced, unresectable or
metastatic pancreatic cancer, in combination with gemcitabine.
Erlotinib is not recommended for use in combination with other
platinum-based chemotherapy.
U.S. sales for Erlotinib Hydrochloride Tablets, 25 mg, 100 mg
and 150 mg were approximately $212
million for the 12 months ending March 31, 2019, according to IQVIA.
Currently, Mylan has 165 ANDAs pending FDA approval representing
approximately $82.2 billion in annual
brand sales, according to IQVIA. Forty-six of these pending ANDAs
are potential first-to-file opportunities, representing
$56.4 billion in annual brand sales,
for the 12 months ending December 31,
2018, according to IQVIA.
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 more than 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.
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SOURCE Mylan N.V.