STAT Plus: FDA rebukes Sprout over a statement claiming warning on its female libido pill was removed
At the insistence of regulators, Sprout Pharmaceuticals has recanted statements made in a press release last week that indicated the Food and Drug Administration had eased various restrictions concerning its controversial female libido pill.
The Sept. 4 press release maintained the agency removed a ban on the use of alcohol with the Addyi pill, a point of contention between Sprout and the FDA for the past few years. The release also suggested the FDA eliminated a safety requirement that physicians and pharmacists had to be certified to prescribe and dispense the medicine, respectively.
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