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These side effects may occur in as many as 90% of men treated with bicalutamide monotherapy, [29] but gynecomastia is generally reported to occur in 70 to 80% of patients. [30] In the EPC trial, at a median follow-up of 7.4 years, breast pain and gynecomastia respectively occurred in 73.6% and 68.8% of men treated with 150 mg/day bicalutamide ...
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
The lawsuits drove the company to declare bankruptcy in 1995, before it agreed to pay $2.3 billion to settle claims from 240,000 women in amounts ranging from $2,000 to $250,000 each in 2004 ...
The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2013, ordered by the size of the total settlement. The settlement amount includes both the civil (False Claims Act) settlement and criminal fine.
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The following is a list of the 21 largest civil settlements, reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2017, ordered by the size of the total civil settlement. Some of these matters also resolved criminal fines and penalties, listed in parentheses, but these amounts are not considered when ...
A federal judge once again encouraged a settlement in the collective action lawsuit that could cost the Central Bucks School District at least $50 million if female teachers prevail in their ...