One year following the approval of the gemcitabine intravesical system, Joseph Jacob, MD, reflects on the expanding treatment landscape in BCG-unresponsive NMIBC.
|Articles|November 16, 2006
Generic versions of oxybutynin gain approval for OAB
The FDA has granted approval to two generic versions of extended-release oxybutynin chloride for the treatment of overactive bladder.
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The FDA has granted approval to two generic versions of extended-release oxybutynin chloride for the treatment of overactive bladder. Mylan Laboratories received final approval for 5- and 10-mg extended-release tablets, and IMPAX Laboratories received approval for 15-mg extended-release tablets. Both companies said the products would be launched immediately.
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A limited market release of SpaceOAR Flex is expected to begin in the US later this year.
The PDUFA target action date is in the fourth quarter of 2026.
The approval is supported by data from the phase 3 LITESPARK-011 trial.
Pearls & Perspectives: Expanding Sexual Health Conversations Through Digital Media, With Wendy Brant
Amy Pearlman, MD, and Wendy Brant discuss building a digital audience, navigating sexual health content online, and the role of communication in relationships.
Positive safety and efficacy data from 4 clinical studies supported the CE marking.
Sandip Prasad, MD, discusses patient selection for chemoablation in recurrent LG-IR-NMIBC and considerations when counseling patients about a nonsurgical approach.
In a head-to-head RCT, Rezūm produced a 4.6-point greater IPSS improvement than combination pharmacotherapy at 1 year, according to Jean-Nicolas Cornu, MD, PhD, FEBU.
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