Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

Menu

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
My View
Tags:
Consumer OTC Drugs

HYDROCORTISONE/PRAMOXINE COMBINATION FOR ANORECTAL ITCH IS NON-MONOGRAPH

This article was originally published in The Tan Sheet

  • News
  • The Tan Sheet

Executive Summary

HYDROCORTISONE/PRAMOXINE COMBINATION FOR ANORECTAL ITCH IS NON-MONOGRAPH and requires clinical studies showing the effectiveness of both ingredients as a combination drug product, FDA told Ferndale Laboratories' attorney Gary Yingling of the Washington, D.C. firm McKenna & Cuneo. In a Jan. 13 letter, FDA said it has "determined that the data and information do...not provide sufficient evidence to demonstrate that each of the active ingredients in the combination product contributes to the claimed effects."

Table

View full table

Topics

Tags:
Consumer OTC Drugs
Latest Headlines

Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity

Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy

Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List

Pink Sheet Podcast: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics

See All
UsernamePublicRestriction

Register

PS082455

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By