Pink Sheet 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
UsernamePublicRestriction

NME Exclusivity Petitions Expand; Ferring Request For Colon-Cleansing Combo Has Urgency

Executive Summary

Ferring requests five years of marketing exclusivity for Prepopik; Gilead also has asked FDA to award five years of exclusivity for active ingredients in a combination product that has not been previously approved, but Gilead has patents to fall back on while Ferring has none.

You may also be interested in...



All Over But The Lawsuits? NCE Exclusivity For Fixed-Dose Combos Remains Prospective

FDA rejects requests by firms to make new policy retroactive; Gilead’s Harvoni and Eisai’s Akynzeo fixed combos, approved the day FDA issued its final guidance, granted exclusivity.

FDA Changes Its Policy On Exclusivity For Fixed-Combination Products

In response to citizen petitions from Gilead, Ferring and Bayer, FDA issued a draft guidance saying future fixed-combination products that include a previously approved active moiety will be eligible for five years of new chemical entity marketing exclusivity.

Novartis To Pull Valturna From U.S. Market As FDA Warns Of Risks With Aliskiren Meds

FDA warns that use of aliskiren-containing blood pressure drugs with ACE inhibitors or angiotensin receptor blockers may increase risk of kidney impairment, hypotension and hyperkalemia; Novartis to continue to sell four other aliskiren products.

Topics

Related Companies

UsernamePublicRestriction

Register

PS055087

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