POTTERS BAR, England and
PITTSBURGH, March 11, 2015 /PRNewswire/ -- Mylan N.V.
(NASDAQ: MYL) and Mylan Inc. today announced the U.S. launch of
Disulfiram Tablets USP, 250 mg and 500 mg, which is the generic
version of Odyssey Pharmaceutical's Antabuse®. 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 an aid in the management of selected chronic
alcohol patients who want to remain in a state of enforced sobriety
so that supportive and psychotherapeutic treatment may be applied
to the best advantage.(1)
Disulfiram Tablets USP, 250 mg and 500 mg, had U.S. sales of
approximately $16.4 million for the
12 months ending December 31, 2014,
according to IMS Health.
Currently, Mylan has 282 ANDAs pending FDA approval representing
$104.7 billion in annual brand sales,
according to IMS Health. Forty-four of these pending ANDAs are
potential first-to-file opportunities, representing $27.3 billion in annual brand sales, for the 12
months ending June 30, 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 approximately 40% 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.
(1) Disulfiram should never be administered to a patient
when he is in a state of alcohol intoxication, or without his full
knowledge. Disulfiram plus alcohol, even small amounts, produce
flushing, throbbing in head and neck, throbbing headache,
respiratory difficulty, nausea, copious vomiting, sweating, thirst,
chest pain, palpitation, dyspnea, hyperventilation, tachycardia,
hypotension, syncope, marked uneasiness, weakness, vertigo, blurred
vision, and confusion. In severe reactions there may be
respiratory depression, cardiovascular collapse, arrhythmias,
myocardial infarction, acute congestive heart failure,
unconsciousness, convulsions, and death.
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SOURCE Mylan N.V.