HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

US Zantac Sales And Distribution Continue As Sanofi Tests For NDMA

Executive Summary

Novartis, which licensed OTC Zantac for US marketing to Sanofi, stops distribution of the histamine-2 blocker ranitidine to presence of NDMA, a probable carcinogen. Decision doesn’t affect US sales of OTC Zantac in US, where FDA says NDMA found in ingredient is at low levels.

You may also be interested in...



US Health Market In 2019: Unfinished Business Leaves Lasting Impression

Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.

More Recalls Seen For Ranitidine

Sandoz is voluntarily recalling all ranitidine hydrochloride capsules in the US because of “confirmed’ NDMA contamination, while Dr Reddy’s is suspending global shipments of the generic version of Zantac due to worries about the presence of the suspected cancer-causing agent in its products, as suppliers around the world grapple with the issue.

Apotex First In US To Recall OTC Ranitidine Tablets Due To NDMA Impurity

Apotex recalls 13 OTC ranitidine tablet products it provided to Walmart, Walgreens and Rite Aid. FDA has no information on plans by nine other firms that, like Apotex, have approved ANDAs for copies of Zantac 75- and 150-mg tablets, which also remain available.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

RS149234

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