French medicines regulator takes Bayer acne drug Diane-35 off market
Following a recent investigation (The Pharma Letter January 29), the French medicines agency (ANSM) announced yesterday its plan to suspend the marketing authorization for German drug major Bayer’s (BAYN: DE) Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and its generics for acne treatment in France.
These medicines are widely used across Europe. They have been authorized at the level of individual European Union member states for many years, notes the European Medicines Agency. In France, they are only authorized for the treatment of acne, but in a number of other member states they are also authorized for the treatment of acne in women who wish to receive oral contraception, as well as for the treatment of other skin conditions.
Drug also used off-label as contraceptive
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