Perrigo says that its partner Cobrek Pharmaceuticals, has filed an Abbreviated New Drug Application for clindamycin phosphate foam 1%, a generic version of fellow USA-based Stiefel's Evoclin Foam 1%, which it believes is the first to file an ANDA with a Paragraph IV certification against this drug.
Evoclin Foam 1% is a topical antibiotic indicated for the treatment of acne vulgaris, and had sales of about $44.0 million for the 12 months ended January 2009, as measured by Wolters Kluwer Health.
The ANDA for the generic product, which was filed prior to enactment of the First Quarter Program Supplemental Funding Act of 2008, was timely amended to contain a Paragraph IV Certification in accordance with the Q1 Act.
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