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.

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

DIPHENHYDRAMINE CITRATE WILL BE OKAYED AS OTC ANTIHISTAMINE

Executive Summary

DIPHENHYDRAMINE CITRATE WILL BE OKAYED AS OTC ANTIHISTAMINE in the final monograph for the product class, FDA told Miles, Bristol-Myers and Richardson-Vicks in recent letters. "The division [of OTC Drug Evaluation] intends to recommend to the commissioner that diphenhydramine citrate be included as an active ingredient in the antihistamine final monograph," FDA told the companies. The three firms had all requested Category I status for the ingredient after the tentative final monograph (TFM) for antihistamines came out in January 1985. The TFM classified the hydrochloride form of diphenhydramine in Category I but did not include the citrate form. However, FDA concluded in a separate final rule for nighttime sleep aids, published Feb. 14, that the citrate salt of diphenhydramine can be considered identical to the hydrochloride salt. In that rulemaking, the agency determined that a dose of 76 mg diphenhydramine citrate is equivalent to 50 mg diphenhydramine HCl. Diphenhydramine citrate is among the ingredients in Miles' Alka-Seltzer Plus Night-Time Cold Medicine and Bristol-Myers' Excederin PM. FDA said it will recommend the following directions for use of diphenhydramine citrate in the antihistamine monograph: "Adults and children 12 years of age and older: oral dosage is 38 to 76 mg every 4 to 6 hours, not to exceed 456 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 19 to 38 mg every 4 to 6 hours, not to exceed 228 mg in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor." Professional labeling for children aged 2-6 will state: "oral dosage is 9.5 mg every 4 to six hours, not to exceed 57 mg in 24 hours." * FDA is still reviewing the status of diphenhydramine HClas an antitussive. The agency recently informed Warner-Lambert that review of their petition to include the ingredient in the monograph is ongoing. "The data in support of your petition are currently being reviewed by the agency in the Division of OTC Drug Evaluation and the Division of Oncologic and Pulmonary Drug Products," FDA said. "However, because of other priorities that require the reviewers' time...the agency was unable to reach a final decision...within 180 days of the date your request was filed."

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

Latest Headlines
See All
UsernamePublicRestriction

Register

PS016718

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