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The FDA issued a warning letter to Tramadol US, calling on the company to stop selling prescription drugs, including opioids, directly to consumers on the 25 websites the company operates. Read More
A federal judge in California has ruled that Gilead Sciences must face a pay-for-delay lawsuit over alleged unlawful payments to India-based Cipla to block competition for Gilead’s former blockbuster HIV drug Truvada (emtricitabine, tenofovir disoproxil fumarate). Read More
Indivior must face a federal jury over allegations that it tried to maintain its monopoly on Suboxone by switching to a sublingual formulation just as other companies were launching generic versions of the opioid antagonist. Read More
Controversy often arises around FDA’s drug approval decisions when the system fails to produce reliable evidence of risks and benefits, says FDA Commissioner Robert Califf, alluding to recent criticism of the agency for bypassing advisory committee recommendations. Read More