The FDA says the company will receive a response on approval of its first product for the US market by July 1.
Kamada Ltd. (TASE: KMDA) which develops drugs on the basis of human plasma, mainly for respiratory conditions, received encouraging news from the US Food and Drug Administration (FDA) today. The FDA has informed Kamada by letter that it that it will receive a final response on approval of its ATT product, in the version administered intravenously, by July 1.
The letter gives no information about actual approval of the product for sale in the US, but it indicates that the answer will be positive. Kamada's share price rose 5.6% on the news, giving the company a market cap of NIS 703 million.
If the approval is forthcoming, intravenous ATT will be Kamada's first product on the US market. The product will be sold as a treatment for congenital Alpha-1 Antitrypsin deficiency with demonstrable panacinar emphysema, a rare but severe respiratory disease.
Published by Globes [online], Israel business news - www.globes-online.com - on March 24, 2010
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