Bayer Seeks FDA OK to Extend Mirena Duration to Six Years

Date : 10/21/2019 @ 3:13PM
Source : Dow Jones News
Stock : Bayer Aktiengesellschaft (PK) (BAYRY)
Quote : 19.46  -0.06 (-0.31%) @ 9:29PM

Bayer Seeks FDA OK to Extend Mirena Duration to Six Years

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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.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

October 21, 2019 10:58 ET (14:58 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

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