With OTC Lidocaine, Salonpas Takes Path Of Less Resistance To Market
This article was originally published in The Pink Sheet
Hisamitsu America looked to the OTC lidocaine market after deciding it would have to wait too long for an ANDA approval for an Rx generic. "We really saw the opportunity in the OTC space with a 4% OTC patch," says President and CEO John Incledon.
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"Our eyes are more on Advil, Tylenol. We want to be considered first-line treatment for pain, for pain appropriate for what our products are," says Hisamitsu America CEO John Incledon.
NAD cases do not go to FTC with a guarantee of enforcement, but firms should not ignore NAD requests for substantiation. FTC declined to enforce against Hisamitsu’s claims for Salonpas OTC pain relief patches after the firm declined to provide information for a NAD review prompted by a Pfizer challenge.
Sales of Promescent, an OTC external analgesic indicated for premature ejaculation available for 18 months online, jumped in the past year with distribution by urologists and other doctors. “The PE space is wide open. That is nothing short of amazing to me,” says Absorption Pharmaceuticals CEO Jeff Abraham.