Sano Habitrol generic transdermal patch could be marketed by Par Pharmaceuticals.
This article was originally published in The Tan Sheet
Executive Summary
SANO HABITROL GENERIC PATCH COULD BE MARKETED BY PAR if FDA approves the company's ANDA for a version of Ciba's nicotine transdermal patch for smoking cessation, according to a recent prospectus for a proposed public offering. Sano filed its ANDA in January 1995, has "received comments from the FDA...and has responded to those comments," the prospectus states. Miramar, Fla.-based Sano's manufacturing facilities passed an FDA preapproval inspection in July 1996. Ciba's Habitrol patents expire in 2003 and 2006.