Innovo Incontinence Device Goes OTC In US, Labeled To Be Worn For 30 Minutes
Atlantic Therapeutics estimates that one in three women are incontinent, but 60% don’t ask their health care providers about treatment, a statistic that supports offering Innovo OTC less than two years after it launched Rx in the US.
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UK ASA upholds complaints that questioned claims made in 2018 TV ads that Innovo was clinically proven to strengthen the pelvic floor and treat bladder weakness. In the US, however, claims Atlantic Therapeutics will use to promote OTC sales of Innovo were approved by FDA.
A snapshot of medical device approvals captured in Medtech Insight's Approvals Tracker. A muscle stimulation device to treat urinary incontinence passed US FDA's review, while a peripheral artery stent with a new delivery system gained European sign off.
Private labeler Perrigo has eyed launching a generic since FDA approved the 3.9mg oxybutynin transdermal as a first-in-class OTC in 2013. Currently, though, Perrigo says it is "not a big product" and is talking about other prescription OAB products that could be approved for OTC.