FDA approves Depomed's urinary tract treatment
Key points
- Food and Drug Administration approved its extended-release antibiotic Proquin XR as a treatment for urinary tract infections, making it the company's first approved product.
- The once-daily, extended-release formulation of ciprofloxacin hydrochloride is the first version of Bayer's antibiotic Cipro to list nausea and diarrhea as "uncommon" adverse events in its label, rather than "common" adverse events, Depomed said.
- In contrast to Cipro and its generic equivalents that release their entire dosage within about 30 minutes, Proquin XR releases its full dosage over 6 hours, avoiding large dosages hitting the intestinal tract all at once.
- Even once-daily Cipro XR releases its dosage within about 2 hours, the company said.
Specialty drugmaker Depomed Inc. Friday said the U.S. Food and Drug Administration approved its extended-release antibiotic Proquin XR as a treatment for urinary tract infections, making it the company's first approved product.
The once-daily, extended-release formulation of ciprofloxacin hydrochloride is the first version of Bayer's antibiotic Cipro to list nausea and diarrhea as "uncommon" adverse events in its label, rather than "common" adverse events, Depomed said.
In contrast to Cipro and its generic equivalents that release their entire dosage within about 30 minutes, Proquin XR releases its full dosage over 6 hours, avoiding large dosages hitting the intestinal tract all at once.
Even once-daily Cipro XR releases its dosage within about 2 hours, the company said.
Depomed said it is in negotiations with potential marketing partners.
Shares of Depomed rose 63 cents to $4.70 on the Inet electronic network, up from a close of $4.07 on Thursday on Nasdaq.
Written and revised by
David Cohen, M.D.
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