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

Perrigo expects private-label MiraLAX launch in October

This article was originally published in The Tan Sheet

Executive Summary

The firm prepares to be market-ready when Schering-Plough's exclusivity expires Oct. 6 for its OTC laxative MiraLAX. The expiry brings the "market formation date" and Perrigo expects "to be there," said Art Shannon, VP of investor relations and communications. Without exclusivity for the innovator, other firms can ask FDA to approve abbreviated new drug applications for equivalent products. Firms do not receive ANDA approval for the product until closer to Oct. 6, Shannon explained

You may also be interested in...



MiraLAX generic

Perrigo expects to ship immediately its OTC laxative polyethylene glycol 3350, powder to solution, following FDA approval of an abbreviated new drug application. Positioned as an equivalent to Schering-Plough Healthcare Products' MiraLAX laxative, the OTC drug will be sold under store-brand labels, the company notes. Perrigo had said it would be market-ready when Schering's exclusivity for the laxative drug expired Oct. 6 (1"The Tan Sheet" July 13, 2009)

US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising

US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS103115

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