HERTFORDSHIRE, England and
PITTSBURGH, Sept. 14, 2015 /PRNewswire/ -- Mylan N.V.
(Nasdaq: MYL) today announced the U.S. launch of Ampicillin and
Sulbactam for Injection USP, 1.5 g/vial (1 g Ampicillin as the
Sodium Salt and 0.5 g Sulbactam as the Sodium Salt), and 3 g/vial
(2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium
salt), and 15 g, Pharmacy Bulk Package, (10 g Ampicillin as
the Sodium Salt and 5 g Sulbactam as the Sodium Salt), the generic
version of Pfizer's Unasyn®. Mylan received final approval from the
U.S. Food and Drug Administration (FDA) for its Abbreviated New
Drug Application (ANDA) for these products, which are indicated for
the treatment of infections due to susceptible strains of
designated microorganisms in skin and skin structure infections,
intra-abdominal infections and gynecological infections.
Ampicillin and Sulbactam for Injection USP, 1.5 g/vial and 3
g/vial and 15 g, Pharmacy Bulk Package, had U.S. sales of
approximately $29 million for the 12
months ending June 30, 2015,
according to IMS Health. Mylan's launch of this product adds to the
company's growing portfolio of more than 145 injectable products
available to patients in the U.S. across a broad array of
therapeutic categories including oncology, anti-infectives,
anesthesia/pain management and cardiovascular.
Currently, Mylan has 262 ANDAs pending FDA approval representing
$99.3 billion in annual brand sales,
according to IMS Health. Fifty of these pending ANDAs are potential
first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12
months ending December 31, 2014,
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 around 1,400 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral
therapies, upon which nearly 50% of HIV/AIDS patients in developing
countries depend. We also operate one of the largest active
pharmaceutical ingredient manufacturers and currently market
products in about 145 countries and territories. Our workforce of
approximately 30,000 people is dedicated to creating better health
for a better world, one person at a time. Learn more at
mylan.com.
Logo - http://photos.prnewswire.com/prnh/20140423/77793
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mylan-launches-generic-unasyn-for-injection-300141995.html
SOURCE Mylan N.V.