Taro Pharmaceuticals Announces FDA Approval; Agency Approves ANDA For Clobetasol Propionate Topical Solution USP, 0.05%

Business Wire, Nov 19, 1998

Hawthorne, N.Y.--(BUSINESS WIRE)--Nov. 19, 1998--Taro Pharmaceutical Industries Ltd. (Nasdaq/NM:TAROF) Thursday reported that it received notification from the U.S. Food and Drug Administration (FDA) approving its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Solution by the company's wholly owned subsidiary, Taro Pharmaceuticals Inc., of Ontario, Canada.

Taro's Clobetasol Propionate Solution is a high-potency topical corticosteroid indicated for the treatment of moderate to severe dermatologic conditions. Clobetasol Propionate Solution is bioequivalent to Glaxo Wellcome's Temovate(R) Scalp Application. The U.S. market for Clobetasol Propionate Solution USP, 0.05% is estimated by industry sources to be approximately $16 million.

Clobetasol Propionate Topical Solution USP, 0.05% is an important extension to Taro's existing line of Clobetasol products, which include Clobetasol Propionate Ointment USP, 0.05% and Clobetasol Propionate Cream USP, 0.05%.

"This approval will further assist in what has been very successful growth in clobetasol market share for Taro in the United States," stated Robert Mauro, group vice president of Sales for North America.

Taro currently has multiple regulatory filings in Canada and Israel, and 7 ANDAs currently submitted to the FDA.

Taro Pharmaceutical Industries is a multinational pharmaceutical company whose research and development program has resulted in the company being the first generic marketer of several branded drugs, as well as the developer of several novel pharmaceutical compounds.

For further information on Taro Pharmaceutical Industries, visit the company's Web site at http://www.taropharma.com.

To receive additional information on Taro Pharmaceutical Industries, at no charge, dial 800/PRO-INFO and enter company code 104 or ticker symbol TAROF.