Dutch Ophthalmic’s VisionBlue Detailing Will Cite Sterility Problems With Compounded Versions
This article was originally published in The Pink Sheet Daily
Custom Rx Compounding Pharmacy issues a nationwide recall of all unexpired syringes of trypan blue 0.06% ophthalmic solution following two reports of vision loss.
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Dutch Ophthalmic’s VisionBlue is the first product approved for staining the anterior lens capsule during cataract surgery, FDA says. Safety and effectiveness of trypan blue ophthalmic solution were established in pediatric patients; no differences have been observed between elderly and younger patients.
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A draft agreement between industry and FDA that would assess user fees for "advisory review" of broadcast direct-to-consumer ads prior to initial public dissemination had its genesis in the Pharmaceutical Research & Manufacturers of America's DTC guiding principles