Bayer Aktiengesellschaft (PK) (USOTC:BAYRY)
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By Colin Kellaher
Bayer AG (BAYN.XE) on Monday said it filed a supplemental new-drug application with the U.S. Food and Drug Administration seeking to extend the approved duration of its Mirena intrauterine device to six years.
The Leverkusen, Germany, chemical-and-pharmaceutical company said the request is based on results from a phase 3 extension trial evaluating the efficacy and safety of the contraceptive.
Mirena, which in 2000 became the first hormonal intrauterine device cleared for use in the U.S., is currently approved to prevent pregnancy for up to five years.
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(END) Dow Jones Newswires
October 21, 2019 10:58 ET (14:58 GMT)
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