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

Zogenix’s Stand-alone Hydrocodone To Stand Before Advisory Panel

This article was originally published in The Pink Sheet Daily

Executive Summary

If approved, Zohydro will be the first extended-release version of hydrocodone and the first not to be combined with other painkillers.

You may also be interested in...



Hurricane Sandy Rains On User Fee Dates, Advisory Committees

FDA will extend user fee goal dates as needed to account for the loss of two days in review cycles resulting from the government office shutdown. The extreme weather conditions led to cancellation of three advisory committees during the week of Oct. 29.

Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment

REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.

Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?

Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.

Topics

Related Companies

Related Deals

UsernamePublicRestriction

Register

PS073490

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