Warning Letters Demand Stop to Unapproved Ergotamine Manufacture and Distribution - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Warning Letters Demand Stop to Unapproved Ergotamine Manufacture and Distribution


ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document

Rockville, MD (Mar. 1)—Sending Warning Letters to eight manufacturers and 12 distributors, the US Food and Drug Administration (www.fda.gov) ordered a stop to the manufacture and distribution of unapproved drug products containing ergotamine tartrate. The action does not affect FDA-approved products containing ergotamine. Most of the companies receiving the letters have omitted from their drugs’ labeling a critical warning regarding the potential for “serious, possibly fatal, interactions with certain other drugs,” including potent CYP 3A4 inhibitors, according to the agency.

“Unapproved drugs pose real risks to the American public,” said Steven Galson, MD, director of FDA’s Center for Drug Evaluation and Research, in a public statement. “It is central to our mission to ensure a safe and effective drug supply for the American public.”

FDA estimates that less than 2% of prescribed drugs on the market are unapproved and continues to combat the marketing of unapproved drugs through its Unapproved Drugs Initiative.

Companies receiving the Feb. 26 Warning Letters are Actavis Totowa LLC; Anabolic Laboratories; Bio Pharm Inc.; Breckenridge Pharmaceutical Inc.; Centrix Pharmaceutical Inc.; DRX Pharmaceutical Consultants Inc.; DSC Laboratories; Excellium Pharmaceutical Inc.; Ferndale Laboratories, Inc.; IVAX Pharmaceuticals Inc. (formerly Goldline Laboratories Inc.); Kaiser Foundation Hospitals; Lini Inc.; Murfreesboro Pharmaceutical Nursing Supply; Nucare Pharmaceuticals, Inc.; Qualitest Pharmaceuticals, Inc;  Sandoz, Inc.; The Harvard Drug Group LLC (formerly Major Pharmaceuticals Inc.); United Research Laboratories Inc. and Mutual Pharmaceutical Company; and Vintage Pharmaceuticals Inc.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here