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market because they are "identical, related or similar" to Wyeth's Wyanoids HC rectal suppositories "whose NDA has been withdrawn."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."
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.
The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
