Healthcare Industry News:  Dermik 

Biopharmaceuticals Generics FDA

 News Release - November 17, 2006

Fougera Receives Approval for First Generic Sulfacetamide Sodium Topical Suspension USP 10% (Rx)

MELVILLE, N.Y., Nov. 17 (HSMN NewsFeed) -- Specialty pharmaceutical manufacturer Fougera, a division of ALTANA Inc, announced today 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 KLARONĀ® 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 began shipping today.

David Klaum, Senior Vice President, Commercial Business Operations, said, "Fougera will be first to market with generic Sulfacetamide Sodium Topical Suspension USP 10% (Rx), 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.

For more information on Sulfacetamide Sodium Topical Suspension USP 10% (Rx) or any other quality Fougera product, please call Fougera Customer Service at (800) 645-9833 or visit the company online at http://www.fougera.com.


Source: Fougera

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