Salonpas patch packaging
This article was originally published in The Tan Sheet
FDA approves a supplemental new drug application for a 3-count sample package of Salonpas Pain Relief Patch and Salonpas Arthritis Pain, the agency says in an Aug. 25 letter to Hisamitsu Pharmaceutical. The NDA for the methyl salicylate and 1-menthol topical patches originally received approval in February. Transdermal patch maker Hisamitsu, whose U.S. operations are based in Torrance, Calif., said the products are "the first FDA-approved OTC topical analgesic patch with great elasticity and snugness," and are more effective than placebo patches for relief of mild to moderate muscle pains
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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)
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