HERTFORDSHIRE, England
and PITTSBURGH,
June 3, 2016
/PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today
announced the U.S. launch of Clindamycin Palmitate Hydrochloride
for Oral Solution USP, 75 mg/5 mL, which is a generic version of
Pharmacia and Upjohn's Cleocin® Solution. Mylan received
final approval from the U.S. Food and Drug Administration (FDA) for
its Abbreviated New Drug Application (ANDA) for this product, which
is indicated for the treatment of serious infections caused by
susceptible anaerobic bacteria and susceptible strains of
streptococci, pneumococci and staphylococci when less toxic
alternatives are inappropriate.(1)
Clindamycin Palmitate Hydrochloride for Oral Solution USP,
75 mg/5 mL, had U.S. sales of approximately $30.9 million for the 12 months ending
March 31, 2016, according to IMS
Health.
Currently, Mylan has 253 ANDAs pending FDA approval
representing $108.2 billion in annual
brand sales, according to IMS Health. Forty-three of these pending
ANDAs are potential first-to-file opportunities, representing
$37.2 billion in annual brand sales,
for the 12 months ending December 31,
2015, 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 1,400 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world depend.
We market our products in approximately 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
nearly 35,000-strong workforce is dedicated to creating better
health for a better world, one person at a time. Learn more at
mylan.com.
(1) Clostridium difficile associated diarrhea
(CDAD) has been reported with use of nearly all antibacterial
agents, including clindamycin and may range in severity from mild
diarrhea to fatal colitis. Treatment with antibacterial agents
alters the normal flora of the colon leading to overgrowth
of C.difficile. Because clindamycin therapy has been
associated with severe colitis which may end fatally, it should be
reserved for serious infections where less toxic antimicrobial
agents are inappropriate.
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SOURCE Mylan N.V.