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

UDL LABS' REPACKAGED DRUGS MUST IDENTIFY MANUFACTURER

Executive Summary

UDL LABS' REPACKAGED DRUGS MUST IDENTIFY MANUFACTURER in the product packaging, FDA told the Rockford, Illinois-based firm in a March 12 regulatory letter. FDA cited three drug products (4 mg chlorpheniramine maleate, 5 mg diazepam tabs, and 12.5 mg meclazine tabs) as misbranded "in that the labels (unit-dose package) fail to bear the place of business of the manufacturer, packer, or distributor as required." The packaging for the three drug products does include the name of UDL. However, FDA said that the company violated the FD&C Act "by failing to qualify the name 'UDL Labs, Inc.'" The packaging, FDA maintains, "represents that UDL Labs is the manufacturer, [which] is contrary to the fact." Noting that UDL has argued that its unit-dose labels "are too small to accommodate all the required information," FDA said it believes "that a careful review of each label will indicate that by rearrangement of the information on the label and a judicious utilization of the label space, all the required information can be accommodated." The agency is requesting UDL to examine all its unit-dose labels and advise FDA "which labels [the firm] will revise to accommodate all the information" and provide FDA with "a sample of each with the revised information." The agency also is asking for samples of labeling that UDL feels are too small to include the required information. The reg letter provides UDL with the standard 10 days to report to FDA what action the firm "will take to revise the labels" and "dispose of...stocks of misbranded drug products." The agency asks that the firm's reply include: an estimate of the quantity of drug received and packaged in unit-dose containers within the past 12 months; an estimate of the size and frequency of shipments for each drug made by the company in the last 12 months; an estimate of the amount of drug in inventory and distribution; and the date of discontinuance if a product has already been discontinued.

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

PS017176

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