(Reuters) - U.S. health regulators said on Monday that there was no evidence of increased cardiovascular risks related to Novartis AG’s treatment, Stalevo, for Parkinson’s disease.
Recommendations for using the drug, which won U.S. approval in 2003, will remain the same on the labels, the U.S. Food and Drug Administration said, after examining data from a required clinical trial and one additional study. (1.usa.gov/1R9cqP6)
The agency had warned patients and healthcare professionals about such risks in August 2010, after it identified certain issues in a clinical trial comparing Stalevo with a combination of drugs, carbidopa and levodopa.
The combination treatment has not shown any increased cardiovascular risks.
U.S-listed shares of the Swiss drugmaker were little changed at $92.33 on the New York Stock Exchange on Monday.
Reporting By Samantha Kareen Nair in Bengaluru; Editing by Anil D'Silva