Schering-Plough Lotrimin AF Ingredient Monograph Status Granted
This article was originally published in The Tan Sheet
Executive Summary
The OTC topical antifungal drug products final monograph will be amended to include clotrimazole 1%, the active ingredient in Schering-Plough Healthcare's Lotrimin AF.
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Topical antifungals monograph
FDA issues final rule in Feb. 8 Federal Register recognizing clotrimazole 1% as safe and effective treatment for athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) under topical antifungal drug products final monograph. Active ingredient in Schering-Plough's Lotrimin AF has been marketed OTC under an NDA since 1989. Agency estimates reg could result in one-time relabeling costs of $50,000-$75,000. FDA originally announced its intention to amend the monograph in May (1"The Tan Sheet" May 28, 2001, p. 3)...
Topical antifungals monograph
FDA issues final rule in Feb. 8 Federal Register recognizing clotrimazole 1% as safe and effective treatment for athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) under topical antifungal drug products final monograph. Active ingredient in Schering-Plough's Lotrimin AF has been marketed OTC under an NDA since 1989. Agency estimates reg could result in one-time relabeling costs of $50,000-$75,000. FDA originally announced its intention to amend the monograph in May (1"The Tan Sheet" May 28, 2001, p. 3)...
Topical antifungals monograph
FDA issues final rule in Feb. 8 Federal Register recognizing clotrimazole 1% as safe and effective treatment for athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) under topical antifungal drug products final monograph. Active ingredient in Schering-Plough's Lotrimin AF has been marketed OTC under an NDA since 1989. Agency estimates reg could result in one-time relabeling costs of $50,000-$75,000. FDA originally announced its intention to amend the monograph in May (1"The Tan Sheet" May 28, 2001, p. 3)...