Taro Receives FDA Approval for Sulfacetamide Sodium Topical Suspension ANDA
Thu, 05/21/2009 - 4:39am
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.