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Efficacy Overstatements In Evofem’s Phexxi Brochure, Otsuka’s Rexulti TV Ad Draw Untitled Letters

 
• By Brenda Sandburg

US FDA releases two letters on the same day citing two different kinds of advisements for two different kinds of products, but both with a classic problem: overstatement of efficacy. And while sending multiple letters at once can be seen as bid to draw attention to its enforcement action, the move also underscores just how few letters the agency has been sending lately.

Objection letter
FDA sends letters objecting to promotions for a contraceptive and an antidepressive. • Source: Shutterstock

The US Food and Drug Administration’s Office of Prescription Drug Promotion issued untitled letters to Evofem Biosciences, Inc. and Otsuka Pharmaceutical Development and Commercialization Inc. objecting to promotions that overstated the efficacy of their products, bringing the number of enforcement letters OPDP has issued this year to five.

The agency issued both letters on 31 October and posted them on its website 8 November. And while sending multiple letters at once can be seen as bid to draw...

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