The FDA cleared the device based on data from a placebo-controlled, randomized, double-blind, parallel group clinical study.
Posimir is a novel formulation of bupivacaine, an amide local anesthetic, designed to be administered directly into the surgical site.
Approval was based on a prospective study that evaluated the effectiveness of the Primary Relief device in 60 patients who underwent cardiac surgery.
SP-103 is a next generation triple strength formulation of ZTlido (lidocaine topical system) 1.8%.
The final rule takes effect in 60 days and consumers will be able to purchase hearing aids directly from stores or online retailers as soon as mid-October.
Under the EUA, Jynneos can be administered either intradermally for individuals aged ≥18 years or subcutaneously for individuals aged <18 years.
FlexBurst360 therapy provides pain coverage across up to 6 areas of the trunk and/or limbs and enables adjustable programming.
The approval was based on data from the phase 3 SPIRIT program, which included the SPIRIT 1 and 2 studies, as well as the first 28 weeks of an open-label extension study.
To address the ongoing COVID-19 related iodinated contrast media product shortage, Iomeron will be temporarily available in the US starting at the end of August 2022.
The designation was based on data from 2 phase 2 proof-of-concept studies that evaluated VX-548 for acute pain following abdominoplasty or bunionectomy surgery.
