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


MiraLAX Targeted In Petition To FDA, But Physicians Back Pediatric Use

This article was originally published in The Tan Sheet

Executive Summary

A consumer group petitions FDA for a black box warning on Merck’s MiraLAX and generic equivalents, citing the potential for adverse reactions in children. Gastroenterologists largely have not seen such risks from off-label pediatric use of the OTC laxative.

You may also be interested in...

Metoclopramide Gets Boxed Warning, REMS, For Movement Disorder Risk

FDA issued a class-wide requirement Feb. 26 for metoclopramide-containing products to gain a boxed warning and Risk Evaluation and Mitigation Strategy to address the gastrointestinal drug's associated risk of tardive dyskinesia

S-P Brings New Laxative Class To OTC Market Under Braintree Licensing Deal

Schering-Plough will position Braintree Laboratories' MiraLAX laxative as an effective treatment for occasional constipation without "harsh" side effects linked to other OTC laxative products

NaZura’s Lovidia Weight-Loss Supplement Strategy Focused On Brand Building

NaZura BioHealth, spun out from Elcelyx Therapeutics, will market its Lovidia weight-loss product in 2014 when it launches into the direct-response channel, before potential suitors get serious about acquiring the brand.


Related Companies

Latest Headlines
See All



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