NVS » Topics » Zelnorm/Zelmac

This excerpt taken from the NVS 6-K filed Apr 22, 2008.
Zelnorm/Zelmac (USD 2 million, –98% lc), for irritable bowel syndrome and chronic constipation, will not be resubmitted for US regulatory approval. This medicine was suspended in the US in March 2007, and subsequently in many other countries, to comply with a request from the FDA to review cardiovascular safety data. However, Zelnorm/Zelmac remains available in some countries, and Novartis will discuss next steps with local health authorities, as requested. An emergency treatment access program remains open in the US to provide Zelnorm to appropriate patients.

 

This excerpt taken from the NVS 6-K filed Feb 8, 2008.
Zelnorm/Zelmac (USD 88 million, -84% lc), for irritable bowel syndrome and chronic constipation, was suspended in the US in March 2007, and subsequently in several other countries, to comply with a request from the FDA to review cardiovascular safety data. A treatment access program was started in the US to provide
This excerpt taken from the NVS 6-K filed Jan 23, 2008.
Zelnorm/Zelmac (USD 88 million, –84% lc), for irritable bowel syndrome and chronic constipation, was suspended in the US in March 2007, and subsequently in many other countries, to comply with a request from the FDA to review cardiovascular safety data. A treatment access program was started in the US to provide Zelnorm to appropriate patients. Novartis continues to believe Zelnorm/Zelmac offers important benefits to appropriate patients, and discussions continue with various health authorities.

 

This excerpt taken from the NVS 6-K filed Jul 19, 2007.

Zelnorm/Zelmac

Novartis affiliates are defendants in three lawsuits filed in US state courts. Plaintiffs claim to have experienced permanent injuries, including severe chest pain, angina and heart attack. These cases are at an early stage.

 

This excerpt taken from the NVS 6-K filed Apr 26, 2007.
Zelnorm/Zelmac (USD 105 million, –3% lc), a treatment for irritable bowel syndrome and chronic constipation, has been suspended from marketing and sales in the US to comply with a request from the FDA to review recent cardiovascular safety data. This product has also been suspended in seven other countries worldwide. Novartis believes Zelnorm/Zelmac provides important benefits for appropriate patients and will continue working with the FDA and health authorities in other countries to secure access for these patients.

 

This excerpt taken from the NVS 6-K filed Feb 14, 2007.
Zelnorm/Zelmac (USD 561 million, +34% lc), for treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, has benefited from outstanding US growth due to broader use of the product and ongoing disease awareness programs.

This excerpt taken from the NVS 6-K filed Jan 24, 2007.
Zelnorm/Zelmac (USD 561 million, +34% lc), for treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, has benefited from outstanding US growth due to broader use of the product and ongoing disease awareness programs.

 

This excerpt taken from the NVS 6-K filed Oct 24, 2006.
Zelnorm/Zelmac (USD 408 million, +38% lc), for treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation, performed well based on strong US growth as well as ongoing disease awareness programs.

 

This excerpt taken from the NVS 6-K filed Jul 18, 2006.
Zelnorm/Zelmac (USD 263 million, +44% lc), for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation, maintained strong growth as use in the US reached an all-time high of 270,000 total prescriptions in May 2006, a 28% increase over May 2005. Increasing awareness about the disease has driven growth for Zelnorm, which is approved in over 55 countries for IBS-C and in more than 20 countries for chronic constipation.

 

This excerpt taken from the NVS 6-K filed Apr 27, 2006.
Zelnorm/Zelmac (USD 109 million, +36% lc), for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation, maintained good double-digit growth rates, benefiting from increasing awareness of the diseases and the product’s benefits. Total prescriptions in the US reached an all-time high in January 2006, up 33% from the year-earlier period. An opinion by the Committee for Medicinal Products (CHMP) issued in March against European approval does not impact
This excerpt taken from the NVS 6-K filed Jan 20, 2006.
Zelnorm/Zelmac in its new chronic constipation indication and also benefited from the normalization of inventories compared to below-average levels in the year-ago period. Novartis will appeal an opinion from a European Medicines Agency (EMEA) committee recommending against EU approval of Zelnorm. This product has been approved in 56 countries for treatment of women with irritable bowel syndrome with constipation (IBS-C).

 

This excerpt taken from the NVS 6-K filed Sep 21, 2005.
Zelnorm/Zelmac (tegaserod), is currently under review by the EMEA for approval in the EU for the treatment of irritable bowel syndrome with constipation (IBS-C). Two Phase III clinical trials with Zelnorm, which was approved in the US in 2004, are currently ongoing for the treatment of dyspepsia, and both are planned to be completed in 2006. Data from a proof-of-concept study in GERD (gastroesophageal reflux disease) is being analyzed following the recent completion of the study.

 

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