Specialty pharmaceutical manufacturer Fougera, a division of Altana Inc, announced has received FDA approval to bring to market the first generic Sulfacetamide Sodium Topical Suspension USP 10 per cent. The generic formulation compares to Klaron by Dermik, whose patent has expired. The market for the brand name product was approximately $25 million in 2005.
Sulfacetamide Sodium Topical Suspension USP 10 per cent is indicated for the topical treatment of acne. The Fougera product (NDC #0168-0382-04) will be available in 118 mL (4 fl oz) bottles and will begin shipping .
David Klaum, senior vice president, Commercial Business Operations, said, "Fougera will be first to market with generic Sulfacetamide Sodium Topical Suspension USP 10 per cent, continuing our track record of receiving more topical generic FDA approvals than any other company during the past six years. The introduction of this product is another example of Fougera's continuing commitment to offer healthcare providers an ever expanding product portfolio to meet their patients' needs."
Fougera is a leading manufacturer and distributor of a wide range of multi-source topical steroids, antibiotics and antifungal products, as well as ophthalmic pharmaceuticals, in both prescription and over-the-counter dosage forms.