Taro Pharmaceutical Industries Ltd. reported today that its Canadian manufacturing site has received approval from the FDA for its Abbreviated New Drug Application 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(r) 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.
