Taro Receives FDA Approval For Sulfacetamide Sodium Topical Suspension ANDA

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 24 May 2009 - 0:00 PDT

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Taro Pharmaceutical Industries Ltd. ("Taro," the "Company," Pink Sheets: TAROF) reported that its Canadian manufacturing site has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Sulfacetamide Sodium Topical Suspension USP, 10% (lotion) ("sulfacetamide sodium lotion").

Sulfacetamide sodium lotion is a prescription product used for the topical treatment of acne and is bioequivalent to the reference listed drug, Sanofi-Aventis' Klaron® Lotion, 10%. According to industry sources, branded and generic prescription sulfacetamide sodium lotion products (10%) had U.S. sales of approximately $15 million in the 12 months ending March 31, 2009.

Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.

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Taro Pharmaceutical Industries Ltd