PARKE-DAVIS ANUSOL HC SUPPOSITORIES ARE NOT SIMILAR TO DES/-INEFFECTIVE

PARKE-DAVIS ANUSOL HC SUPPOSITORIES ARE NOT SIMILAR TO DES/-INEFFECTIVE Wyanoids HC, Parke-Davis main tains. "Anusol HC suppositories, an Rx product distinct from OTC Anusol, is not identical, similar or otherwise related to the DESI reviewed product in question. It differs both in formula and clinical indications. We are discussing the issue with FDA," Parke-Davis said. The firm's statement was in response to a recent FDA regulatory letter, issued as part of the DESI program, which stated that Anusol HC suppositories may not remain on the market because they are "identical, related or similar" to Wyeth's Wyanoids HC rectal suppositories "whose NDA has been withdrawn." FDA announced it was withdrawing approval of Wyanoids HC in the Sept. 12 Federal Register. Labelling for Anusol HC states that the suppositories and cream formulations are indicated for "adjunctive therapy for the symptomatic relief of pain and discomfort in: external and internal hemorrhoids, proctitis, papillitis, cryptitis, anal fissures, incomplete fistulas and relief of local pain and discomfort following anorectal surgery." Wyanoids HC is indicated in approved labelling as "'possibly' effective [in the] treatment of proctitis secondary to ulcerative colitis." The active ingredients in Anusol HC suppositories are: hydrocortisone acetate 10 mg, bismuth subgallate 2.25%, bismuth resorcin compound 1.75%, benzyl benzoate 1.2%, Peruvian balsam 1.8%, and zinc oxide 11%. Wyanoids HC suppositories contain "10 mg hydrocortisone acetate, 15 mg extract belladonna (0.19 mg equiv. total alkaloids), 3 mg ephedrine sulfate, 176 mg zinc oxide, 543 mg boric acid, 30 mg bismuth oxyiodide, 146 mg bismuth subcarbonate, 30 mg Peruvian balsam in coca butter and beeswax," the appoved labelling states. As part of the DESI review system the agency also notified at least 15 generic mfrs. of Roche's Roniacol (nicotinyl alcohol) tablets, including Par, Bolar and Generix, that their products should not continue on the market. FDA withdrew approval of the NDAs for these products by notice in a Sept. 12 Federal Register notice. Labeling for Roniacol states the drug is "'possibly' effective: In conditions associated with deficient circulation; e.g., peripheral vascular disease, vascular spasm, varicose ulcers, decubital ulcers, chilblains, Meniere's syndrome and vertigo. Another set of DESI regulatory letters was issued to mfrs. of certain combination products containing dicyclomine HCI and phenobarbital for the treatment of gastrointestinal conditions. Bolar, Henry Schein, Geneva Generics, Generix and at least 20 others firms received notice that they should notify the agency of "the action you will take to discontinue the marketing of this drug product(s) and any other applicable drug which you may market."