FDA actions in brief
Sodium phosphate monobasic monohydrate/sodium phosphate dibasic anhydrous tablets (OsmoPrep, Salix) were approved by FDA for cleansing of the colon prior to colonoscopy in patients aged 18 years or older.
Sodium phosphate monobasic monohydrate/sodium phosphate dibasic anhydrous tablets (OsmoPrep, Salix) were approved by FDA for cleansing of the colon prior to colonoscopy in patients aged 18 years or older.
FDA approved omeprazole/sodium bicarbonate (Zegerid, Santarus), an immediate-release proton pump inhibitor (PPI), for the short-term treatment of active duodenal ulcers and erosive esophagitis diagnosed by endoscopy, the short-term treatment of active benign gastric ulcers, the maintenance of healing of erosive esophagitis, and for heartburn and other symptoms associated with gastroesophageal reflux disease (GERD).
FDA Accepts NDA for Zoliflodacin, Potentially First Gonorrhea Antibiotic in Decades
June 13th 2025The FDA has accepted a New Drug Application for zoliflodacin, a first-in-class oral antibiotic for treating uncomplicated gonorrhea, offering a potential new option amid rising antibiotic resistance.
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