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

Alkermes/Cephalon Plan Vivitrol Launch In Q2 Following "Approvable" Letter

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Alkermes and Cephalon are preparing a second quarter launch of Vivitrol, a once-monthly naltrexone injection for the treatment of alcohol dependence, after receiving an "approvable" letter from FDA.

You may also be interested in...



Alkermes Vivitrol "complete response"

Alkermes' alcoholism treatment Vivitrol (extended-release naltrexone injection) could be approved as early as April if FDA accepts the firm's response to a Dec. 28, 2005 "approvable" letter as a Class 1 response. The response, announced Feb. 17, includes some additional data but no additional clinical studies. The approvable letter requested preclinical pharmacokinetic data to support reference to existing oral naltrexone preclinical data via Vivitrol's 505(b)(2) NDA (1Pharmaceutical Approvals Monthly January 2006, p. 28)…

Vivitrex 90-day extension

FDA's user fee deadline for Cephalon/Alkermes' once-monthly injectable naltrexone formulation Vivitrex is Dec. 30 following a 90-day extension, the firms announce Sept. 20. The extension stems from a recent response being reclassified as a major amendment. Vivitrex is receiving a priority review for treatment of alcoholism (1Pharmaceutical Approvals Monthly June 2005, In Brief)...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

Topics

UsernamePublicRestriction

Register

LL1133951

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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