The US Food and Drug Administration has approved Sandoz' Tavist-D and Tavist-1 (clemastine fumarate) products, for the relief of cold symptoms including sneezing and a runny nose.
Although Tavist is already available on the market, and has been since 1992, the approval means that the FDA has accepted clinical research put forward by the company, and that Sandoz is now able to incorporate this claim on its new labeling for the products.
"The FDA's decision is especially significant because the studies conducted on all other antihistamines to support cold symptom effectiveness so far have been judged inconclusive by the FDA," said Mark Gelbert, executive director of scientific affairs for Sandoz.
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