Hisamitsu seeks barriers for Salonpas generics

Hisamitsu Pharmaceutical Co. petitions FDA to require generic competition for its Salonpas Pain Relief Patch to submit specific clinical data as part of abbreviated new drug applications. The agency should reject any ANDA without a placebo-controlled clinical investigation, a standard battery of skin safety studies and a pharmacokinetic study centered on the generic patch formulation, the Japanese firm says in its Dec. 31 citizen 1petition. Further, the generic product should have the same surface area and active ingredient amounts as Salonpas, Hisamitsu says. FDA approved Salonpas' NDA in February 2008, and the company says it is unaware of any other successful NDAs for OTC topical external analgesics (2"The Tan Sheet" Sept. 1, 2008, In Brief). Reckitt Benckiser used a similar strategy in a bid to raise the bar for generic versions of Mucinex, but FDA denied its petition (see story p. 5)