HBW Insight 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

Latest OTC Homeopathic Firm Using Rx Indications Also A Repeat GMP Offender

Executive Summary

FDA says Newton Laboratories sells unapproved Rx homeopathics because its products are labeled to treat diseases and conditions including allergies, chicken pox and “suicidal tendency.” Warning letter says firm also has repeatedly violated same GMPs across more than a decade of inspections.

You may also be interested in...



Remediations For Three Homeopathic Firms, End Of Production For Another

FDA warning letters require lengthy remediation plans from Kadesh. and two of its contract manufacturers, Fill It Pack It and WePackItAll. The third manufacturer, US Continental Marketing, told FDA it has stopped making drugs.

King Bio Tops List Of Homeopathic Firms FDA Warns In Show Of Enforcement

FDA warns King Bio, three other homeopathic product marketers. In addition to GMP deficiencies, "we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer,” says FDA Commissioner Gottlieb.

FDA Reprimands Snake Venom Seller For Pain Claims Amid Opioid Crisis

Nutra Pharma’s Nyloxin claims to relieve cancer pain and potentially help treat opioid addiction, among others, mark its products as unapproved new drugs, FDA asserts in a warning letter that reflects its homeopathic enforcement approach proposed in late 2017.  “Health fraud scams like these are inexcusable,” says FDA Commissioner Scott Gottlieb.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS148771

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