July 2, 2020 · FLEMING | NOLEN | JEZ, L.L.P.
Elmiron® is the only drug approved by the Federal Drug Administration for the treatment of interstitial cystitis, which is a painful bladder condition that affects millions of women. Recent studies suggest that Elmiron® may cause a rare, potentially permanent eye disease known as pigmentary maculopathy. Even more troubling is the fact that pigmentary maculopathy can be mistakenly diagnosed as age-related…
June 16, 2020 · FLEMING | NOLEN | JEZ, L.L.P.
The FDA must approve a prescription drug before the manufacturer can sell it in the United States. Ordinarily, the approval process requires that the manufacturer first present clinical trial data as evidence for the effectiveness and safety of the drug. If a drug is too dangerous, or if the drug is not effective in treating the condition for which it…