Perrigo’s partner files ANDA for generic acne drug

Perrigo Company, a healthcare supplier, has reported that its partner Cobrek Pharmaceuticals has filed an abbreviated new drug application for clindamycin phosphate foam 1%, a generic version of Evoclin foam 1%.

Evoclin (clindamycin phosphate) Foam 1% is a topical antibiotic indicated for topical application in the treatment of acne vulgaris. The company believes that Cobrek is the first to file an abbreviated new drug application (ANDA) with a Paragraph IV certification against Evoclin.

The ANDA for clindamycin phosphate foam, 1%, which was filed prior to enactment of the Q1 Program Supplemental Funding Act of 2008 (the ‘Q1 Act’), was timely amended to contain a Paragraph IV Certification in accordance with the Q1 Act. On March 13, 2009, Stiefel filed suit alleging patent infringement in the US District Court of Delaware against Perrigo and its partner Cobrek.

Stiefel also has filed a citizen petition with the FDA seeking to have a 30 month stay of Cobrek’s ANDA approval imposed. The FDA has not ruled, neither have the courts, regarding whether the Q1 Act entitles Stiefel to a 30-month stay.

Joseph Papa, Perrigo’s chairman and CEO, said: This filing reflects our continuing investment in new products. We are the manufacturer and developer of this product as well as the exclusive sales and marketer. As always, Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders.