European Panel OKs Bayer Acne Drug For Some Women

Law360, New York (May 17, 2013, 4:46 PM EDT) -- A European Medicines Agency committee on Friday backed the use of Bayer AG's acne drug Diane 35 in limited circumstances, months after France's drug watchdog halted sales of the medication over blood clot risks.

The agency's Pharmacoviligance Risk Assessment Committee determined that the benefits of Diane 35 and generic versions of the drug outweigh its risks, as long as it is reserved for moderate to severe acne related to an androgen sensitivity or excessive hair growth in women. In addition, the drug should only be used...
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