Dermatology

Fougera receives approval for first generic Sulfacetamide Sodium Topical Suspension USP 10% (Rx)

Published in Medical Patent Business Week, December 22nd, 2006

Specialty pharmaceutical manufacturer Fougera, a division of ALTANA Inc, announced that it has received FDA approval to bring to market the first generic Sulfacetamide Sodium Topical Suspension USP 10% (Rx).

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% (Rx) is indicated for the topical treatment of acne. The Fougera product (NDC #0168-0382-04) is available in 118 mL (4 fl oz) bottles and has begun shipping.

David Klaum, senior vice president, commercial business operations,...

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Source: Medical Patent Business Week (2006-12-22)

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