Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) said today that it has received final US Food and Drug Administration (FDA) approval for to market a generic version of acne medication Solodyn.
Teva's product is a generic version of Medicis Pharmaceutical Corporation's Solodyn (Minocycline HCl) extended-release tablets, in dosages of 45, 90, and 135 miligrams.
The FDA approved Teva's abbreviated new drug application. As one of the first companies to file the application, Teva has been awarded a 180-day period of marketing exclusivity. Shipment of this product has commenced.
Based on IMS sales data, annual sales in the US of Solodyn were about $365 million for the twelve months that ended January 31.
Teva is currently involved in patent litigation concerning Solodyn, and a trial date has not been set.
Shares in Teva fell 0.74% to $45.32 in early trading, giving it a market cap of $40.28 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on March 18, 2009
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