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

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.