Teva's BuSpar tentatively approved

Drug Store News, Sept 10, 2001 by Diane West, Jennifer E. Smith

The Food and Drug Administration awarded tentative approval for buspirone HCl tablets 15 mg to Teva last month. With this approval, Teva has tentative approvals for the three strengths of buspirone HCl tablets: 5 mg, 10 mg and 15 mg. Buspirone HCl tablets are the generic version of Bristol-Myers Squibb's BuSpar for the treatment of anxiety and anxiety with depression.

Annual sales of the brand's 15 mg product in the United States are estimated to be $395 million. Teva expects to begin marketing the product at the end of this month.