Healthcare Industry News:  arrhythmia 

Biopharmaceuticals Generics FDA

 News Release - March 11, 2015

Mylan Launches Generic Antabuse(R) Tablets

POTTERS BAR, England and PITTSBURGH, March 11, 2015 -- (Healthcare Sales & Marketing Network) -- Mylan N.V. (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.


Source: Mylan

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