Zelnorm's Return: US FDA Panel Hands Down Split Decision On Constipation Drug's Target Population
Seven advisory committee members said the treatment for irritable bowel syndrome with constipation should be labeled for females at low cardiovascular risk; three panelists, including two cardiologists, supported a narrower indication limited to low CV risk patients who also suffer from severe symptoms.
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Zelnorm Returning To US Market With Broad IBS-C Indication
US FDA limiting use of Zelnorm, originally pulled from the market in 2007 by its then-sponsor Novartis, to adult women who are at low CV risk, but tegaserod is not restricted to patients who are severely symptomatic for IBS-C.
Takeda’s Uloric: CV Mortality Signal Leads US FDA To Ponder Regulatory Options
Advisory committee will discuss whether CARES postmarketing trial showing 34% increased risk of cardiovascular death for febuxostat warrants market withdrawal, use restrictions, or new labeling for the gout drug.
The New Zelnorm-al: US FDA’s Do-Over On Cardiovascular Safety
Zelnorm’s revival is self-conscious effort to revisit a decision made in “Safety First” era a decade ago. Is dropping CV outcomes standard for diabetes drugs next?