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Zelnorm Returning To US Market With Broad IBS-C Indication

 
• By Michael Cipriano

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. 

The Photo Of Large Intestine Is On The Woman's Body. People With Stomach Ache Problem Concept. Female Anatomy

The US FDA has given Zelnorm (tegaserod maleate) the green light to return to the US market with a broad indication for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C) who are at low cardiovascular (CV) risk.

The new label for Zelnorm, a serotonin-4 (5-HT4) receptor agonist now owned by US WorldMeds LLC, contains a...

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More from Approvals

EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

More from Product Reviews

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.